21 CFR Part 870 — Cardiovascular Devices
Subpart A — General Provisions
Subpart B — Cardiovascular Diagnostic Devices
- § 870.1025— Arrhythmia detector and alarm (including ST-segment measurement and alarm).
- § 870.1100— Blood pressure alarm.
- § 870.1110— Blood pressure computer.
- § 870.1120— Blood pressure cuff.
- § 870.1130— Noninvasive blood pressure measurement system.
- § 870.1140— Venous blood pressure manometer.
- § 870.1200— Diagnostic intravascular catheter.
- § 870.1210— Continuous flush catheter.
- § 870.1220— Electrode recording catheter or electrode recording probe.
- § 870.1230— Fiberoptic oximeter catheter.
- § 870.1240— Flow-directed catheter.
- § 870.1250— Percutaneous catheter.
- § 870.1251— Temporary catheter for embolic protection during transcatheter intracardiac procedures.
- § 870.1252— Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
- § 870.1255— Balloon aortic valvuloplasty catheter.
- § 870.1270— Intracavitary phonocatheter system.
- § 870.1280— Steerable catheter.
- § 870.1290— Steerable catheter control system.
- § 870.1300— Catheter cannula.
- § 870.1310— Vessel dilator for percutaneous catheterization.
- § 870.1330— Catheter guide wire.
- § 870.1340— Catheter introducer.
- § 870.1342— Reverse central venous recanalization system.
- § 870.1345— Intravascular bleed monitor.
- § 870.1350— Catheter balloon repair kit.
- § 870.1360— Trace microsphere.
- § 870.1370— Catheter tip occluder.
- § 870.1380— Catheter stylet.
- § 870.1390— Trocar.
- § 870.1405— Interventional cardiovascular implant simulation software device.
- § 870.1415— Coronary vascular physiologic simulation software device.
- § 870.1420— Coronary artery disease risk indicator using acoustic heart signals.
- § 870.1425— Programmable diagnostic computer.
- § 870.1435— Single-function, preprogrammed diagnostic computer.
- § 870.1450— Densitometer.
- § 870.1650— Angiographic injector and syringe.
- § 870.1660— Indicator injector.
- § 870.1670— Syringe actuator for an injector.
- § 870.1750— External programmable pacemaker pulse generator.
- § 870.1800— Withdrawal-infusion pump.
- § 870.1875— Stethoscope.
- § 870.1915— Thermodilution probe.
Subpart C — Cardiovascular Monitoring Devices
- § 870.2050— Biopotential amplifier and signal conditioner.
- § 870.2060— Transducer signal amplifier and conditioner.
- § 870.2100— Cardiovascular blood flowmeter.
- § 870.2120— Extravascular blood flow probe.
- § 870.2200— Adjunctive cardiovascular status indicator.
- § 870.2210— Adjunctive predictive cardiovascular indicator.
- § 870.2220— Adjunctive hemodynamic indicator with decision point.
- § 870.2300— Cardiac monitor (including cardiotachometer and rate alarm).
- § 870.2310— Apex cardiograph (vibrocardiograph).
- § 870.2320— Ballistocardiograph.
- § 870.2330— Echocardiograph.
- § 870.2340— Electrocardiograph.
- § 870.2345— Electrocardiograph software for over-the-counter use.
- § 870.2350— Electrocardiograph lead switching adaptor.
- § 870.2360— Electrocardiograph electrode.
- § 870.2370— Electrocardiograph surface electrode tester.
- § 870.2390— Phonocardiograph.
- § 870.2400— Vectorcardiograph.
- § 870.2450— Medical cathode-ray tube display.
- § 870.2600— Signal isolation system.
- § 870.2620— Line isolation monitor.
- § 870.2640— Portable leakage current alarm.
- § 870.2675— Oscillometer.
- § 870.2700— Oximeter.
- § 870.2710— Ear oximeter.
- § 870.2750— Impedance phlebograph.
- § 870.2770— Impedance plethysmograph.
- § 870.2780— Hydraulic, pneumatic, or photoelectric plethysmographs.
- § 870.2785— Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
- § 870.2786— Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
- § 870.2790— Photoplethysmograph analysis software for over-the-counter use.
- § 870.2800— Medical magnetic tape recorder.
- § 870.2810— Paper chart recorder.
- § 870.2840— Apex cardiographic transducer.
- § 870.2850— Extravascular blood pressure transducer.
- § 870.2855— Implantable Intra-aneurysm Pressure Measurement System.
- § 870.2860— Heart sound transducer.
- § 870.2870— Catheter tip pressure transducer.
- § 870.2880— Ultrasonic transducer.
- § 870.2890— Vessel occlusion transducer.
- § 870.2900— Patient transducer and electrode cable (including connector).
- § 870.2910— Radiofrequency physiological signal transmitter and receiver.
- § 870.2920— Telephone electrocardiograph transmitter and receiver.
Subpart D — Cardiovascular Prosthetic Devices
- § 870.3250— Vascular clip.
- § 870.3260— Vena cava clip.
- § 870.3300— Vascular embolization device.
- § 870.3375— Cardiovascular intravascular filter.
- § 870.3450— Vascular graft prosthesis.
- § 870.3460— Endovascular Suturing System.
- § 870.3470— Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
- § 870.3535— Intra-aortic balloon and control system.
- § 870.3545— Ventricular bypass (assist) device.
- § 870.3600— External pacemaker pulse generator.
- § 870.3605— Pacing system analyzer.
- § 870.3610— Implantable pacemaker pulse generator.
- § 870.3620— Pacemaker lead adaptor.
- § 870.3630— Pacemaker generator function analyzer.
- § 870.3640— Indirect pacemaker generator function analyzer.
- § 870.3650— Pacemaker polymeric mesh bag.
- § 870.3670— Pacemaker charger.
- § 870.3680— Cardiovascular permanent or temporary pacemaker electrode.
- § 870.3690— Pacemaker test magnet.
- § 870.3700— Pacemaker programmers.
- § 870.3710— Pacemaker repair or replacement material.
- § 870.3720— Pacemaker electrode function tester.
- § 870.3730— Pacemaker service tools.
- § 870.3800— Annuloplasty ring.
- § 870.3850— Carotid sinus nerve stimulator.
- § 870.3925— Replacement heart valve.
- § 870.3935— Prosthetic heart valve holder.
- § 870.3945— Prosthetic heart valve sizer.
Subpart E — Cardiovascular Surgical Devices
- § 870.4075— Endomyocardial biopsy device.
- § 870.4100— Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
- § 870.4150— Extracorporeal system for carbon dioxide removal.
- § 870.4200— Cardiopulmonary bypass accessory equipment.
- § 870.4205— Cardiopulmonary bypass bubble detector.
- § 870.4210— Cardiopulmonary bypass vascular catheter, cannula, or tubing.
- § 870.4220— Cardiopulmonary bypass heart-lung machine console.
- § 870.4230— Cardiopulmonary bypass defoamer.
- § 870.4240— Cardiopulmonary bypass heat exchanger.
- § 870.4250— Cardiopulmonary bypass temperature controller.
- § 870.4260— Cardiopulmonary bypass arterial line blood filter.
- § 870.4270— Cardiopulmonary bypass cardiotomy suction line blood filter.
- § 870.4280— Cardiopulmonary prebypass filter.
- § 870.4290— Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- § 870.4300— Cardiopulmonary bypass gas control unit.
- § 870.4310— Cardiopulmonary bypass coronary pressure gauge.
- § 870.4320— Cardiopulmonary bypass pulsatile flow generator.
- § 870.4330— Cardiopulmonary bypass on-line blood gas monitor.
- § 870.4340— Cardiopulmonary bypass level sensing monitor and/or control.
- § 870.4350— Cardiopulmonary bypass oxygenator.
- § 870.4360— Nonroller-type blood pump.
- § 870.4370— Roller-type cardiopulmonary bypass blood pump.
- § 870.4380— Cardiopulmonary bypass pump speed control.
- § 870.4390— Cardiopulmonary bypass pump tubing.
- § 870.4400— Cardiopulmonary bypass blood reservoir.
- § 870.4410— Cardiopulmonary bypass in-line blood gas sensor.
- § 870.4420— Cardiopulmonary bypass cardiotomy return sucker.
- § 870.4430— Cardiopulmonary bypass intracardiac suction control.
- § 870.4450— Vascular clamp.
- § 870.4475— Surgical vessel dilator.
- § 870.4500— Cardiovascular surgical instruments.
- § 870.4510— Apical closure device.
- § 870.4875— Intraluminal artery stripper.
- § 870.4885— External vein stripper.
Subpart F — Cardiovascular Therapeutic Devices
- § 870.5050— Patient care suction apparatus.
- § 870.5100— Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
- § 870.5150— Embolectomy catheter.
- § 870.5175— Septostomy catheter.
- § 870.5200— External cardiac compressor.
- § 870.5210— Cardiopulmonary resuscitation (CPR) aid.
- § 870.5225— External counter-pulsating device.
- § 870.5300— DC-defibrillator (including paddles).
- § 870.5310— Automated external defibrillator system.
- § 870.5325— Defibrillator tester.
- § 870.5550— External transcutaneous cardiac pacemaker (noninvasive).
- § 870.5600— Adjunctive open loop fluid therapy recommender.
- § 870.5700— Steerable cardiac ablation catheter remote control system.
- § 870.5800— Compressible limb sleeve.
- § 870.5900— Thermal regulating system.
- § 870.5910— Esophageal thermal regulation device.
- § 870.5925— Automatic rotating tourniquet.