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Title 21 - Title 21
Part 870 - CARDIOVASCULAR DEVICES
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Details about Part 870
Description
MEDICAL DEVICES - CARDIOVASCULAR DEVICES
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154 sections
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§870.1 - Scope.
Title 21, Part 870
§870.1025 - Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Title 21, Part 870
§870.1100 - Blood pressure alarm.
Title 21, Part 870
§870.1110 - Blood pressure computer.
Title 21, Part 870
§870.1120 - Blood pressure cuff.
Title 21, Part 870
§870.1130 - Noninvasive blood pressure measurement system.
Title 21, Part 870
§870.1140 - Venous blood pressure manometer.
Title 21, Part 870
§870.1200 - Diagnostic intravascular catheter.
Title 21, Part 870
§870.1210 - Continuous flush catheter.
Title 21, Part 870
§870.1220 - Electrode recording catheter or electrode recording probe.
Title 21, Part 870
§870.1230 - Fiberoptic oximeter catheter.
Title 21, Part 870
§870.1240 - Flow-directed catheter.
Title 21, Part 870
§870.1250 - Percutaneous catheter.
Title 21, Part 870
§870.1251 - Temporary catheter for embolic protection during transcatheter intracardiac procedures.
Title 21, Part 870
§870.1255 - Balloon aortic valvuloplasty catheter.
Title 21, Part 870
§870.1270 - Intracavitary phonocatheter system.
Title 21, Part 870
§870.1280 - Steerable catheter.
Title 21, Part 870
§870.1290 - Steerable catheter control system.
Title 21, Part 870
§870.1300 - Catheter cannula.
Title 21, Part 870
§870.1310 - Vessel dilator for percutaneous catheterization.
Title 21, Part 870
§870.1330 - Catheter guide wire.
Title 21, Part 870
§870.1340 - Catheter introducer.
Title 21, Part 870
§870.1350 - Catheter balloon repair kit.
Title 21, Part 870
§870.1360 - Trace microsphere.
Title 21, Part 870
§870.1370 - Catheter tip occluder.
Title 21, Part 870
§870.1380 - Catheter stylet.
Title 21, Part 870
§870.1390 - Trocar.
Title 21, Part 870
§870.1415 - Coronary vascular physiologic simulation software device.
Title 21, Part 870
§870.1425 - Programmable diagnostic computer.
Title 21, Part 870
§870.1435 - Single-function, preprogrammed diagnostic computer.
Title 21, Part 870
§870.1450 - Densitometer.
Title 21, Part 870
§870.1650 - Angiographic injector and syringe.
Title 21, Part 870
§870.1660 - Indicator injector.
Title 21, Part 870
§870.1670 - Syringe actuator for an injector.
Title 21, Part 870
§870.1750 - External programmable pacemaker pulse generator.
Title 21, Part 870
§870.1800 - Withdrawal-infusion pump.
Title 21, Part 870
§870.1875 - Stethoscope.
Title 21, Part 870
§870.1915 - Thermodilution probe.
Title 21, Part 870
§870.2050 - Biopotential amplifier and signal conditioner.
Title 21, Part 870
§870.2060 - Transducer signal amplifier and conditioner.
Title 21, Part 870
§870.2100 - Cardiovascular blood flowmeter.
Title 21, Part 870
§870.2120 - Extravascular blood flow probe.
Title 21, Part 870
§870.2200 - Adjunctive cardiovascular status indicator.
Title 21, Part 870
§870.2300 - Cardiac monitor (including cardiotachometer and rate alarm).
Title 21, Part 870
§870.2310 - Apex cardiograph (vibrocardiograph).
Title 21, Part 870
§870.2320 - Ballistocardiograph.
Title 21, Part 870
§870.2330 - Echocardiograph.
Title 21, Part 870
§870.2340 - Electrocardiograph.
Title 21, Part 870
§870.2350 - Electrocardiograph lead switching adaptor.
Title 21, Part 870
§870.2360 - Electrocardiograph electrode.
Title 21, Part 870
§870.2370 - Electrocardiograph surface electrode tester.
Title 21, Part 870
§870.2390 - Phonocardiograph.
Title 21, Part 870
§870.2400 - Vectorcardiograph.
Title 21, Part 870
§870.2450 - Medical cathode-ray tube display.
Title 21, Part 870
§870.2600 - Signal isolation system.
Title 21, Part 870
§870.2620 - Line isolation monitor.
Title 21, Part 870
§870.2640 - Portable leakage current alarm.
Title 21, Part 870
§870.2675 - Oscillometer.
Title 21, Part 870
§870.2700 - Oximeter.
Title 21, Part 870
§870.2710 - Ear oximeter.
Title 21, Part 870
§870.2750 - Impedance phlebograph.
Title 21, Part 870
§870.2770 - Impedance plethysmograph.
Title 21, Part 870
§870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.
Title 21, Part 870
§870.2800 - Medical magnetic tape recorder.
Title 21, Part 870
§870.2810 - Paper chart recorder.
Title 21, Part 870
§870.2840 - Apex cardiographic transducer.
Title 21, Part 870
§870.2850 - Extravascular blood pressure transducer.
Title 21, Part 870
§870.2855 - Implantable Intra-aneurysm Pressure Measurement System.
Title 21, Part 870
§870.2860 - Heart sound transducer.
Title 21, Part 870
§870.2870 - Catheter tip pressure transducer.
Title 21, Part 870
§870.2880 - Ultrasonic transducer.
Title 21, Part 870
§870.2890 - Vessel occlusion transducer.
Title 21, Part 870
§870.2900 - Patient transducer and electrode cable (including connector).
Title 21, Part 870
§870.2910 - Radiofrequency physiological signal transmitter and receiver.
Title 21, Part 870
§870.2920 - Telephone electrocardiograph transmitter and receiver.
Title 21, Part 870
§870.3 - Effective dates of requirement for premarket approval.
Title 21, Part 870
§870.3250 - Vascular clip.
Title 21, Part 870
§870.3260 - Vena cava clip.
Title 21, Part 870
§870.3300 - Vascular embolization device.
Title 21, Part 870
§870.3375 - Cardiovascular intravascular filter.
Title 21, Part 870
§870.3450 - Vascular graft prosthesis.
Title 21, Part 870
§870.3460 - Endovascular Suturing System.
Title 21, Part 870
§870.3470 - Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Title 21, Part 870
§870.3535 - Intra-aortic balloon and control system.
Title 21, Part 870
§870.3545 - Ventricular bypass (assist) device.
Title 21, Part 870
§870.3600 - External pacemaker pulse generator.
Title 21, Part 870
§870.3605 - Pacing system analyzer.
Title 21, Part 870
§870.3610 - Implantable pacemaker pulse generator.
Title 21, Part 870
§870.3620 - Pacemaker lead adaptor.
Title 21, Part 870
§870.3630 - Pacemaker generator function analyzer.
Title 21, Part 870
§870.3640 - Indirect pacemaker generator function analyzer.
Title 21, Part 870
§870.3650 - Pacemaker polymeric mesh bag.
Title 21, Part 870
§870.3670 - Pacemaker charger.
Title 21, Part 870
§870.3680 - Cardiovascular permanent or temporary pacemaker electrode.
Title 21, Part 870
§870.3690 - Pacemaker test magnet.
Title 21, Part 870
§870.3700 - Pacemaker programmers.
Title 21, Part 870
§870.3710 - Pacemaker repair or replacement material.
Title 21, Part 870
§870.3720 - Pacemaker electrode function tester.
Title 21, Part 870
§870.3730 - Pacemaker service tools.
Title 21, Part 870
§870.3800 - Annuloplasty ring.
Title 21, Part 870
§870.3850 - Carotid sinus nerve stimulator.
Title 21, Part 870
§870.3925 - Replacement heart valve.
Title 21, Part 870
§870.3935 - Prosthetic heart valve holder.
Title 21, Part 870
§870.3945 - Prosthetic heart valve sizer.
Title 21, Part 870
§870.4075 - Endomyocardial biopsy device.
Title 21, Part 870
§870.4100 - Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Title 21, Part 870
§870.4200 - Cardiopulmonary bypass accessory equipment.
Title 21, Part 870
§870.4205 - Cardiopulmonary bypass bubble detector.
Title 21, Part 870
§870.4210 - Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Title 21, Part 870
§870.4220 - Cardiopulmonary bypass heart-lung machine console.
Title 21, Part 870
§870.4230 - Cardiopulmonary bypass defoamer.
Title 21, Part 870
§870.4240 - Cardiopulmonary bypass heat exchanger.
Title 21, Part 870
§870.4250 - Cardiopulmonary bypass temperature controller.
Title 21, Part 870
§870.4260 - Cardiopulmonary bypass arterial line blood filter.
Title 21, Part 870
§870.4270 - Cardiopulmonary bypass cardiotomy suction line blood filter.
Title 21, Part 870
§870.4280 - Cardiopulmonary prebypass filter.
Title 21, Part 870
§870.4290 - Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Title 21, Part 870
§870.4300 - Cardiopulmonary bypass gas control unit.
Title 21, Part 870
§870.4310 - Cardiopulmonary bypass coronary pressure gauge.
Title 21, Part 870
§870.4320 - Cardiopulmonary bypass pulsatile flow generator.
Title 21, Part 870
§870.4330 - Cardiopulmonary bypass on-line blood gas monitor.
Title 21, Part 870
§870.4340 - Cardiopulmonary bypass level sensing monitor and/or control.
Title 21, Part 870
§870.4350 - Cardiopulmonary bypass oxygenator.
Title 21, Part 870
§870.4360 - Nonroller-type blood pump.
Title 21, Part 870
§870.4370 - Roller-type cardiopulmonary bypass blood pump.
Title 21, Part 870
§870.4380 - Cardiopulmonary bypass pump speed control.
Title 21, Part 870
§870.4390 - Cardiopulmonary bypass pump tubing.
Title 21, Part 870
§870.4400 - Cardiopulmonary bypass blood reservoir.
Title 21, Part 870
§870.4410 - Cardiopulmonary bypass in-line blood gas sensor.
Title 21, Part 870
§870.4420 - Cardiopulmonary bypass cardiotomy return sucker.
Title 21, Part 870
§870.4430 - Cardiopulmonary bypass intracardiac suction control.
Title 21, Part 870
§870.4450 - Vascular clamp.
Title 21, Part 870
§870.4475 - Surgical vessel dilator.
Title 21, Part 870
§870.4500 - Cardiovascular surgical instruments.
Title 21, Part 870
§870.4510 - Apical closure device.
Title 21, Part 870
§870.4875 - Intraluminal artery stripper.
Title 21, Part 870
§870.4885 - External vein stripper.
Title 21, Part 870
§870.5050 - Patient care suction apparatus.
Title 21, Part 870
§870.5100 - Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
Title 21, Part 870
§870.5150 - Embolectomy catheter.
Title 21, Part 870
§870.5175 - Septostomy catheter.
Title 21, Part 870
§870.5200 - External cardiac compressor.
Title 21, Part 870
§870.5210 - Cardiopulmonary resuscitation (CPR) aid.
Title 21, Part 870
§870.5225 - External counter-pulsating device.
Title 21, Part 870
§870.5300 - DC-defibrillator (including paddles).
Title 21, Part 870
§870.5310 - Automated external defibrillator system.
Title 21, Part 870
§870.5325 - Defibrillator tester.
Title 21, Part 870
§870.5550 - External transcutaneous cardiac pacemaker (noninvasive).
Title 21, Part 870
§870.5700 - Steerable cardiac ablation catheter remote control system.
Title 21, Part 870
§870.5800 - Compressible limb sleeve.
Title 21, Part 870
§870.5900 - Thermal regulating system.
Title 21, Part 870
§870.5910 - Esophageal thermal regulation device.
Title 21, Part 870
§870.5925 - Automatic rotating tourniquet.
Title 21, Part 870
§870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Title 21, Part 870