TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
Subpart A - General Provisions
§ 870.1 - Scope.
§ 870.3 - Effective dates of requirement for premarket approval.
§ 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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).
§ 870.5700 - 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.
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