CDSCO risk classification
Cardiovascular medical device classification
Every cardiovascular device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 9 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 135
- Class A
- 13
- Class B
- 42
- Class C
- 37
- Class D
- 42
Cardiovascular devices and their class
135 devices
Angiographic Catheter
Cardiovascular
Class BDesigned to provide a pathway for delivering contrast media to selected sites in the device vascular system including the carotid arteries.
Angiographic Guide Wire
Cardiovascular
Class DIt delivers radio opaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
Angiographic Syringe Kit
Cardiovascular
Class BIntended to be used for the administration of saline/radiographic contrast media during angiographic investigations. This device does not include high-risk components, viz. angiographic catheter, etc.
Annuloplasty ring
Cardiovascular
Class CAn annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.
Aorta Punch
Cardiovascular
Class BA manual surgical instrument intended for use by cardiac surgeons to create an opening (anastomosis) in the wall of the aortic vessel during cardiac vascular surgery.
Apexcardiograph (vibrocardiograph)
Cardiovascular
Class BAn apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer.
Class taken from Merged existing medical devices risk classification, entry Cardiovascular 3, because the register feed omits it.
Apheresis Kit
Cardiovascular
Class CIntended for the collection and separation of blood components.
Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm)
Cardiovascular
Class CThe arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Arterial Cannula
Cardiovascular
Class BInserted into an artery, commonly the radial artery, and is used during major operations and in critical care areas to measure beat-to-beat blood pressure and to draw repeated blood samples.
Arterial Catheter
Cardiovascular
Class BIntended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature.
Atherectomy Coronary Catheter
Cardiovascular
Class DA catheter containing a rotating cutter and a collecting chamber for debris, used for atherectomy and
Atherectomy Peripheral Catheter
Cardiovascular
Class DIntended for use in atherectomy of the peripheral vasculature.
Balloon Dilatation Vessel Catheter
Cardiovascular
Class BIntended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
Balloon Repair Catheter Kit
Cardiovascular
Class CA device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to affect the repair or replacement.
Balloon Type Catheter
Cardiovascular
Class BSoft catheter with an inflatable balloon at its tip which is used during a catheterization procedure to enlarge a narrow opening or passage within the body.
Bifurcation Stent
Cardiovascular
Class CIntended for improving the side branch luminal diameter of arterial bifurcation liaisons.
Bio Patches
Cardiovascular
Class CIntended for reconstruction and repair of defects of pericardium.
Bioresorbable Vascular Scaffold (BVS) System
Cardiovascular
Class DAn absorbable stent which is placed into a blood vessel (coronary artery) during angioplasty to help keep the coronary artery open.
Blood Filter System
Cardiovascular
Class CIntended for collection and preparation of various blood components.
Blood Pressure Monitoring Devices
Cardiovascular
Class BIt is device used to measure the diastolic and systolic blood pressures.
Blood Pressure Transducer set, non-invasive
Cardiovascular
Class BA collection of sterile, non-invasive devices (including pressure transducer, extension line, high pressure tubing) intended to connect to an appropriate invasive device (e.g., catheter, cannula, etc.) [invasive device not included], to detect blood pressure and transmit them as electrical signals to an appropriate monitoring device for further analysis and display. It is generally used to determine intracardiac pressure, etc. It may be used with a pressure dome. This may contain accessories, such as stopcock, clamp, mounting rod, etc. This is a single-use device.
Cannulact or Lymph Duct
Cardiovascular
Class BA lymph duct is a great lymphatic vessel that empties lymph into one of the subclavian veins.
Cardiac Catheterization Kit
Cardiovascular
Class DCardiac catheterization is a general term for a group of procedures that are performed using this method, such as coronary angiography and left ventricle angiography.
Cardiac mapping system reference patch
Cardiovascular
Class ANon-sterile, non-measuringA non-powered, non-invasive component of a cardiac mapping system that is an adhesive passive device intended to be placed on the surface of a patient's body, typically the chest and/or back, to convey the position of the intracardiac catheter and support catheter navigation and mapping. The system uses the reference patches to help generate positional information for the mapping workflow. It is a non-sterile, single-use device.
Cardiac monitor (including cardiotachometer and rate alarm)
Cardiovascular
Class BA cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Cardiac Thermodilution Catheter
Cardiovascular
Class DA catheter used in thermodilution for in troduction of the cold liquid indicator into thecardiovascular system or for the assessment of a patient’s hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions.
Cardiopulmonary bypass arterial line blood filter
Cardiovascular
Class CA cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.
Cardiopulmonary bypass bubble detector
Cardiovascular
Class BA cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.
Cardiopulmonary bypass cardiotomy suction line blood
Cardiovascular
Class BA cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.
Cardiopulmonary bypass defoamer
Cardiovascular
Class CA cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.
Cardiopulmonary bypass heart-lung machine console
Cardiovascular
Class BA cardiopulmonary bypass heart- lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.
Cardiopulmonary bypass heat exchanger
Cardiovascular
Class BA cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.
Cardiopulmonary bypass pulsatile flow generator
Cardiovascular
Class DA cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator.
Cardiopulmonary bypass temperature controller
Cardiovascular
Class BA cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.
Cardiopulmonary bypass vascular catheter, cannula, or tubing
Cardiovascular
Class BA cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
Cardiovascular Catheter
Cardiovascular
Class DA thin, hollow tube called a catheter is inserted into a large blood vessel that leads to heart.
Cardiovascular permanent or temporary pacemaker electrode
Cardiovascular
Class CA temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
Cardiovascular prosthetic devices
Cardiovascular
Class DAn intra-cardiac patch or pledgete which is a medical device placed in the heart and is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
Carotid Filter System
Cardiovascular
Class CUsed while performing angioplasty and stenting procedures in carotid arteries.
Carotid sinus nerve stimulator
Cardiovascular
Class DA carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the carotid sinus.
Carotid Stent System
Cardiovascular
Class DIndicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
Catheter Guide
Cardiovascular
Class DIt is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). PTCA Guide Wires are not to be used in the cerebral blood vessel.
Catheter Guide Wire
Cardiovascular
Class DIt is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The PTCA Guide Wires are not to be used in the cerebral blood vessel.
Central Venous Catheter Kit
Cardiovascular
Class CIt is indicated for use in patients requiring of administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
Central Venous Catheters
Cardiovascular
Class CIt is indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
Coronary Artery Cannula
Cardiovascular
Class BCannulation technique for left-sided coronary artery surgery.
Coronary dilation catheter
Cardiovascular
Class CIt is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
Coronary stent
Cardiovascular
Class DA coronary stent is a tube-shaped device placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease.
Custom Perfusion System
Cardiovascular
Class CIndicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedure.
Defibrillators
Cardiovascular
Class CIt is a device that automatically analyzes the rhythm of heart of cardiac arrest patients and delivers an electrical shock to the heart for restoring the normal rhythm of heart.
Diagnostic Radiology Catheters
Cardiovascular
Class CAngiography catheters are designed to be used for delivering radioopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Drug eluting stent
Cardiovascular
Class DStent, coronary, drug-eluting - a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Echocardiograph
Cardiovascular
Class BAn echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.
Electrocardiograph
Cardiovascular
Class BAn electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by heart.
Electrocardiograph electrode
Cardiovascular
Class BAn electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
Electrocardiographic (ECG) cable, reusable
Cardiovascular
Class ANon-sterile, non-measuringA noninvasive device intended to conduct electrical signals from a patient's heart, via an electrode [not included] attached to the surface of the chest/limbs and lead wires [not included], to an electrocardiograph (ECG) machine or a patient monitoring system [not included]. It does not include ECG electrodes. This is a reusable device.
Electrode Recording Probe, Electrode Recording Catheter
Cardiovascular
Class not statedA cardiac catheter containing one or more electrodes; it may be used to pace the heart or to deliver high energy shocks.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Electrophysiology Catheter Connection Cable
Cardiovascular
Class AA sterile accessory intended to electrically connect a compatible electrophysiology ablation catheter [not included] with the associated electrophysiology (EP) system [not included] for transmission of electrical signals and/or delivery of ablation energy. This is a single-use device.
Embolectomy Catheter
Cardiovascular
Class DIndicated for the removal of fresh, soft emboli and
Embolic Filter System
Cardiovascular
Class DIt is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting system procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5 mm.
Endomyocardial biopsy device
Cardiovascular
Class DAn endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.
Endoscopic Ligation Devices
Cardiovascular
Class BIt is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
Extension Guidewire
Cardiovascular
Class AA long, thin, sterile wire designed to provide the necessary length to allow the exchange of one coronary artery dilatation catheter [not included] for another, while maintaining the position of the cardiac catheter guidewire [not included] in the coronary artery, during angiography or percutaneous transluminal coronary angioplasty (PTCA). It is joined to the proximal end of the in situ guidewire. After the catheter exchange, the guidewire extension can be detached and the guidewire used as intended. This is a single-use device.
External cardiac compressor
Cardiovascular
Class CAn external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).
External transcutaneous cardiac pacemaker
Cardiovascular
Class CAn external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure
Cardiovascular
Class CAn extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patients blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).
Extracorporeal Ultraviolet Blood Irradiator System
Cardiovascular
Class CA powered device intended for extracorporeal irradiation of a measured volume of blood with ultraviolet radiation as an aid in reducing the microbiological burden (viral/bacterial) in patient blood. The blood is taken out and reinfused into the patient in a closed circuit. This may include IV administration sets and other accessories (e.g., IV pole) for reinfusion of blood into the patient. This is not intended for treating specific blood components.
Fiberoptic Oximeter Catheter
Cardiovascular
Class BIntended for monitoring the balance between oxygen delivery and consumption at the bedside.
Flow Directed Catheter
Cardiovascular
Class BUsed for venous sampling and pressure monitoring.
Forceps, haemostatic, reusable
Cardiovascular
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to constrict blood vessels during surgery to prevent bleeding for transient period of time. This is a transient-use, reusable device.
Guiding Catheter
Cardiovascular
Class BThe guide catheter provides support for device advancement.
Heart valve
Cardiovascular
Class DA device intended to perform the function of any of the heart's natural valves.
Heart Valve annulus Sizer
Cardiovascular
Class BA manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve [not included] will be implanted.
Hemoconcentrator set
Cardiovascular
Class CA hemoconcentrator is a fluid removal device used during cardio bypass surgery. The device is inserted into the extracorpeal circuit where it acts to control hemodilution, maintain hematocrit levels and reduce the need for additional blood products during and after surgery.
Hert-Lung Bypass Unit Tube
Cardiovascular
Class BA tube will be placed in your heart to drain blood to the machine.
Implantable pacemaker pulse generator
Cardiovascular
Class DAn implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.
Implanted Subcutaneous Intravascular Port and Catheter
Cardiovascular
Class CThe device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood.
Intra-aortic balloon
Cardiovascular
Class CAn intra-aortic balloon is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon.
Intra-aortic balloon and control system
Cardiovascular
Class DIt is a medical device which is placed in the aorta to improve cardiovascular and control system functioning during certain life threatening emergencies.
Intra-aortic balloon control system (balloon pump)
Cardiovascular
Class BAn intra-aortic balloon control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.
Intra-Aortic System Balloon and Control
Cardiovascular
Class DIt is a mechanical device that increases myocardial oxygen perfusion while at the same time increasing cardiac output.
Intraaortic Balloon Catheter
Cardiovascular
Class DIt is indicated for use in patients undergoing cardiopulmonary bypass.
Intracardiac Mapping, High Density Array Catheter
Cardiovascular
Class DA high density array catheter once used in the right atrium to map and diagnosis complex arrhythmias and assess the effectiveness of ablation treatment.
Intracardiac patch
Cardiovascular
Class Dintracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
Intraluminal artery stripper
Cardiovascular
Class BAn intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
Intravascular Diagnostic Catheter
Cardiovascular
Class DUsed to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.
Intravascular Occluding Catheter
Cardiovascular
Class DIt is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms of intracranial blood vessels.
Intravenous Catheter
Cardiovascular
Class BA catheter that is inserted into a vein for supplying medications or nutrients directly into the bloodstream or for diagnostic purposes such as studying blood pressure
Introducer Sheath
Cardiovascular
Class CIntended to provide easier access to the femoral, popliteal and infrapopliteal arteries.
Invasive Pressure Monitoring Tubing
Cardiovascular
Class BA sterile, flexible tube intended to interface a pressure monitoring system/transducer and an invasive catheter/cannula [not included] to carry blood from the patient to the pressure monitoring device to aid in vascular pressure measurements. It may also be used as extension tubing to deliver IV fluids to a patient from an infusion pump. This is a single-use device.
Laser Sheath
Cardiovascular
Class CIntended for use as adjuncts to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
Micro-catheter
Cardiovascular
Class CIt is intended to access the peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and or diagnostic materials such as contrast media.
Multiple lumen catheter
Cardiovascular
Class BIntended for monitoring central venous pressure (CVP) ., sampling blood, and simultaneous administration of multiple IV solutions or drugs.
Non-Invasive Blood pressure (NIBP) Simulator
Cardiovascular
Class AA powered device intended to mimic and simulate the pressure variations acting on the cuff of noninvasive arterial blood pressure monitoring/measuring devices when placed on a patient's arm in order to test and calibrate oscillometric noninvasive blood pressure monitors, sphygmomanometers, patient monitors, etc. It typically simulates blood pressure values (e.g., systolic, diastolic, mean) and abnormal states (e.g, hypertensive, hypotensive). This is a reusable device.
Occlusion Catheter
Cardiovascular
Class DInsertion of a device or develop at any time during the course of intravenous (IV) therapy.
Oximetry catheters, Oximetry Paceport catheter
Cardiovascular
Class BIt is indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery catheters, pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions.
Pacemaker generator function analyzer
Cardiovascular
Class CA pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
Pacemaker lead adaptor
Cardiovascular
Class CA pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.
Pacemaker programmers
Cardiovascular
Class CA pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker.
Pacemaker repair or replacement material
Cardiovascular
Class DA pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.
Pacemaker test magnet
Cardiovascular
Class ANon-sterile, non-measuringA pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.
Pacing system analyzer
Cardiovascular
Class CA pacing system analyzer (PSA) is a prescription device that combines the functionality of a pacemaker electrode function tester and an external pacemaker pulse generator (EPPG). It is connected to a pacemaker lead and uses a power supply and electronic circuits to supply an accurately calibrated, variable pacing pulse for measuring the patients pacing threshold and intracardiac R-wave potential. A PSA may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.
Percuataneous Intravascular Long Term Catheter
Cardiovascular
Class CThe device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients the sampling of blood.
Percutaneous Catheter
Cardiovascular
Class DA needle catheter getting access to a blood vessel, followed by the introduction of a wire through the lumen (pa thway) of the needle.
Perfusion Catheter
Cardiovascular
Class DPerfusion catheter allowing localised perfusion of drugs not only into the vessel lumen, but also directly into the vessel wall at low pressure, during coronary intervention.
Pericardium Drainage Catheter
Cardiovascular
Class DCatheter drainage of the pericardium.
Peripheral Stent System
Cardiovascular
Class CA Peripheral stent is a tube-shaped device placed in the peripheral arteries that supply blood into body organ.
Peripheral, Transluminal Angioplasty Catheter
Cardiovascular
Class CA catheter for treating peripheral vascular diseases.
Replacement heart valve
Cardiovascular
Class DA replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.
Retractor, cardiovascular, reusable
Cardiovascular
Class ANon-sterile, non-measuringA manual surgical instrument intended for use in cardiothoracic surgery to support stabilisation and positioning of various anatomical structures. It is not intended for use in CABG procedure and/or retraction of incisions in the heart. This is a reusable device intended for transient use.
RETRIEVAL SNARE
Cardiovascular
Class CIntended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial neurovascular anatomy.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
RETRIEVAL SNARE
Cardiovascular
Class DIntended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial neurovascular anatomy.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
RF Conducte MR steerable electrode catheter
Cardiovascular
Class CIt is intended for intracardiac ablation.
Scalp Vein Set
Cardiovascular
Class BIntended to be used for insertion into the patients vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
Septostomy Catheter
Cardiovascular
Class DUsed to enlarge interatrial openings
Subclavian Catheter
Cardiovascular
Class BCatheters can be placed in veins in the neck (internal jugular vein), chest (subclavian vein or auxillary vein).
Surgical bulldog clamp, reusable
Cardiovascular
Class ANon-sterile, non-measuringA manual surgical instrument intended to grasp, join, compress or support an organ, vessel or soft-tissue. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a reusable device intended for transient use.
Thrombectomy Catheter
Cardiovascular
Class DThrombectomy catheter is specifically designed to treat deep vein thrombosis Catheter (DVT) in large-diameter upper and lower peripheral veins.
Transcatheter Heart Valve
Cardiovascular
Class DIt is intended for people with symptomatic aortic stenosis who are considered an intermediate or high risk patient for standard valve replacement surgery.
Transcatheter Heart Valve Crimping Tool
Cardiovascular
Class AA sterile, mechanical, non-invasive instrument intended for the controlled radial crimping of balloon-expandable transcatheter heart valves (THV) prior to implantation using catheter-based delivery systems. It does not come in contact with the patient during its operation. This does NOT include the delivery system, heart valve or any other high-risk heart valve accessory.
Transluminal, Coronary Angioplasty, Percutaneous Catheter
Cardiovascular
Class DThe catheter is placed in the opening or ostium of one the coronary arteries.
Umbilical Artery Catheter
Cardiovascular
Class BUmbilical artery catheterization provides direct access to the arterial blood supply and allows accurate measurement of arterial blood pressure, a source of arterial blood sampling, and intravascular access for fluids and medications.
Vascular clip
Cardiovascular
Class BA vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels.
Vascular compression bandage, reusable
Cardiovascular
Class ANon-sterile, non-measuringA stretchable piece of fabric material intended to provide pressure for haemostasis to a punctured site on a patient having undergone femoral artery catheterization or venipuncture. It may also be used on radial and brachial arteries. It is not a surgical dressing. This is a reusable device after appropriate sterilizing.
Vascular compression system, reusable
Cardiovascular
Class ANon-sterile, non-measuringA noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure. It may in addition be used on brachial and radial arteries or after venipuncture. This is a non-measuring, reusable device.
Vascular embolization device
Cardiovascular
Class DIt is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors.
Vascular graft/occluders/Cardiac Patches
Cardiovascular
Class DIntended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Vascular scissors/ micro- scissors, reusable
Cardiovascular
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery it is not intended for endoscopic use. This is a transient-use, reusable device intended to be sterilized prior to use. Not intended for direct contact with the central circulatory/central nervous system.
Vena Cava Cannula
Cardiovascular
Class BInserted into Vena Cava, taking deoxygenated blood to heart.
Vena cava clip
Cardiovascular
Class BA vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel.
Vena Cava Filter Sets
Cardiovascular
Class CIt is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava to treat various disease conditions.
Venous Cannula
Cardiovascular
Class BIt is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
Ventricular bypass (assist) device
Cardiovascular
Class DA ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
Ventricular Bypass (assistive)
Cardiovascular
Class DA ventricular bypass (assistive) device is a device that assists the left or right ventricle in maintaining circulatory blood flow.
Vessel dilator for percutaneous catheterization
Cardiovascular
Class BA vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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