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FEDERAL · 21 CFR

Part 870 — Cardiovascular Devices

167 sections · Title 21: Food and Drugs

§ 870.1Scope.
§ 870.3Effective dates of requirement for premarket approval.
§ 870.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
§ 870.1100Blood pressure alarm.
§ 870.1110Blood pressure computer.
§ 870.1120Blood pressure cuff.
§ 870.1130Noninvasive blood pressure measurement system.
§ 870.1140Venous blood pressure manometer.
§ 870.1200Diagnostic intravascular catheter.
§ 870.1210Continuous flush catheter.
§ 870.1220Electrode recording catheter or electrode recording probe.
§ 870.1230Fiberoptic oximeter catheter.
§ 870.1240Flow-directed catheter.
§ 870.1250Percutaneous catheter.
§ 870.1251Temporary catheter for embolic protection during transcatheter intracardiac procedures.
§ 870.1252Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
§ 870.1255Balloon aortic valvuloplasty catheter.
§ 870.1270Intracavitary phonocatheter system.
§ 870.1280Steerable catheter.
§ 870.1290Steerable catheter control system.
§ 870.1300Catheter cannula.
§ 870.1310Vessel dilator for percutaneous catheterization.
§ 870.1330Catheter guide wire.
§ 870.1340Catheter introducer.
§ 870.1342Reverse central venous recanalization system.
§ 870.1345Intravascular bleed monitor.
§ 870.1350Catheter balloon repair kit.
§ 870.1360Trace microsphere.
§ 870.1370Catheter tip occluder.
§ 870.1380Catheter stylet.
§ 870.1390Trocar.
§ 870.1405Interventional cardiovascular implant simulation software device.
§ 870.1415Coronary vascular physiologic simulation software device.
§ 870.1420Coronary artery disease risk indicator using acoustic heart signals.
§ 870.1425Programmable diagnostic computer.
§ 870.1435Single-function, preprogrammed diagnostic computer.
§ 870.1450Densitometer.
§ 870.1650Angiographic injector and syringe.
§ 870.1660Indicator injector.
§ 870.1670Syringe actuator for an injector.
§ 870.1750External programmable pacemaker pulse generator.
§ 870.1800Withdrawal-infusion pump.
§ 870.1875Stethoscope.
§ 870.1915Thermodilution probe.
§ 870.2050Biopotential amplifier and signal conditioner.
§ 870.2060Transducer signal amplifier and conditioner.
§ 870.2100Cardiovascular blood flowmeter.
§ 870.2120Extravascular blood flow probe.
§ 870.2200Adjunctive cardiovascular status indicator.
§ 870.2210Adjunctive predictive cardiovascular indicator.
§ 870.2220Adjunctive hemodynamic indicator with decision point.
§ 870.2300Cardiac monitor (including cardiotachometer and rate alarm).
§ 870.2310Apex cardiograph (vibrocardiograph).
§ 870.2320Ballistocardiograph.
§ 870.2330Echocardiograph.
§ 870.2340Electrocardiograph.
§ 870.2345Electrocardiograph software for over-the-counter use.
§ 870.2350Electrocardiograph lead switching adaptor.
§ 870.2360Electrocardiograph electrode.
§ 870.2370Electrocardiograph surface electrode tester.
§ 870.2390Phonocardiograph.
§ 870.2400Vectorcardiograph.
§ 870.2450Medical cathode-ray tube display.
§ 870.2600Signal isolation system.
§ 870.2620Line isolation monitor.
§ 870.2640Portable leakage current alarm.
§ 870.2675Oscillometer.
§ 870.2700Oximeter.
§ 870.2710Ear oximeter.
§ 870.2750Impedance phlebograph.
§ 870.2770Impedance plethysmograph.
§ 870.2780Hydraulic, pneumatic, or photoelectric plethysmographs.
§ 870.2785Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
§ 870.2786Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
§ 870.2790Photoplethysmograph analysis software for over-the-counter use.
§ 870.2800Medical magnetic tape recorder.
§ 870.2810Paper chart recorder.
§ 870.2840Apex cardiographic transducer.
§ 870.2850Extravascular blood pressure transducer.
§ 870.2855Implantable Intra-aneurysm Pressure Measurement System.
§ 870.2860Heart sound transducer.
§ 870.2870Catheter tip pressure transducer.
§ 870.2880Ultrasonic transducer.
§ 870.2890Vessel occlusion transducer.
§ 870.2900Patient transducer and electrode cable (including connector).
§ 870.2910Radiofrequency physiological signal transmitter and receiver.
§ 870.2920Telephone electrocardiograph transmitter and receiver.
§ 870.3250Vascular clip.
§ 870.3260Vena cava clip.
§ 870.3300Vascular embolization device.
§ 870.3375Cardiovascular intravascular filter.
§ 870.3450Vascular graft prosthesis.
§ 870.3460Endovascular Suturing System.
§ 870.3470Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
§ 870.3535Intra-aortic balloon and control system.
§ 870.3545Ventricular bypass (assist) device.
§ 870.3600External pacemaker pulse generator.
§ 870.3605Pacing system analyzer.
§ 870.3610Implantable pacemaker pulse generator.
§ 870.3620Pacemaker lead adaptor.
§ 870.3630Pacemaker generator function analyzer.
§ 870.3640Indirect pacemaker generator function analyzer.
§ 870.3650Pacemaker polymeric mesh bag.
§ 870.3670Pacemaker charger.
§ 870.3680Cardiovascular permanent or temporary pacemaker electrode.
§ 870.3690Pacemaker test magnet.
§ 870.3700Pacemaker programmers.
§ 870.3710Pacemaker repair or replacement material.
§ 870.3720Pacemaker electrode function tester.
§ 870.3730Pacemaker service tools.
§ 870.3800Annuloplasty ring.
§ 870.3850Carotid sinus nerve stimulator.
§ 870.3925Replacement heart valve.
§ 870.3935Prosthetic heart valve holder.
§ 870.3945Prosthetic heart valve sizer.
§ 870.4075Endomyocardial biopsy device.
§ 870.4100Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
§ 870.4150Extracorporeal system for carbon dioxide removal.
§ 870.4200Cardiopulmonary bypass accessory equipment.
§ 870.4205Cardiopulmonary bypass bubble detector.
§ 870.4210Cardiopulmonary bypass vascular catheter, cannula, or tubing.
§ 870.4220Cardiopulmonary bypass heart-lung machine console.
§ 870.4230Cardiopulmonary bypass defoamer.
§ 870.4240Cardiopulmonary bypass heat exchanger.
§ 870.4250Cardiopulmonary bypass temperature controller.
§ 870.4260Cardiopulmonary bypass arterial line blood filter.
§ 870.4270Cardiopulmonary bypass cardiotomy suction line blood filter.
§ 870.4280Cardiopulmonary prebypass filter.
§ 870.4290Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
§ 870.4300Cardiopulmonary bypass gas control unit.
§ 870.4310Cardiopulmonary bypass coronary pressure gauge.
§ 870.4320Cardiopulmonary bypass pulsatile flow generator.
§ 870.4330Cardiopulmonary bypass on-line blood gas monitor.
§ 870.4340Cardiopulmonary bypass level sensing monitor and/or control.
§ 870.4350Cardiopulmonary bypass oxygenator.
§ 870.4360Nonroller-type blood pump.
§ 870.4370Roller-type cardiopulmonary bypass blood pump.
§ 870.4380Cardiopulmonary bypass pump speed control.
§ 870.4390Cardiopulmonary bypass pump tubing.
§ 870.4400Cardiopulmonary bypass blood reservoir.
§ 870.4410Cardiopulmonary bypass in-line blood gas sensor.
§ 870.4420Cardiopulmonary bypass cardiotomy return sucker.
§ 870.4430Cardiopulmonary bypass intracardiac suction control.
§ 870.4450Vascular clamp.
§ 870.4475Surgical vessel dilator.
§ 870.4500Cardiovascular surgical instruments.
§ 870.4510Apical closure device.
§ 870.4875Intraluminal artery stripper.
§ 870.4885External vein stripper.
§ 870.5050Patient care suction apparatus.
§ 870.5100Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
§ 870.5150Embolectomy catheter.
§ 870.5175Septostomy catheter.
§ 870.5200External cardiac compressor.
§ 870.5210Cardiopulmonary resuscitation (CPR) aid.
§ 870.5225External counter-pulsating device.
§ 870.5300DC-defibrillator (including paddles).
§ 870.5310Automated external defibrillator system.
§ 870.5325Defibrillator tester.
§ 870.5550External transcutaneous cardiac pacemaker (noninvasive).
§ 870.5600Adjunctive open loop fluid therapy recommender.
§ 870.5700Steerable cardiac ablation catheter remote control system.
§ 870.5800Compressible limb sleeve.
§ 870.5900Thermal regulating system.
§ 870.5910Esophageal thermal regulation device.
§ 870.5925Automatic rotating tourniquet.