21 C.F.R. PART 870--CARDIOVASCULAR DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 870--CARDIOVASCULAR DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval.
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--CARDIOVASCULAR DIAGNOSTIC DEVICES
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| Arrhythmia detector and alarm (including ST-segment measurement and alarm).
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| Noninvasive blood pressure measurement system.
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| Venous blood pressure manometer.
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| Diagnostic intravascular catheter.
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| Continuous flush catheter.
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| Electrode recording catheter or electrode recording probe.
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| Fiberoptic oximeter catheter.
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| Intracavitary phonocatheter system.
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| Steerable catheter control system.
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| Vessel dilator for percutaneous catheterization.
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| Catheter balloon repair kit.
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| Programmable diagnostic computer.
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| Single-function, preprogrammed diagnostic computer.
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| Angiographic injector and syringe.
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| Syringe actuator for an injector.
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| External programmable pacemaker pulse generator.
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| Withdrawal-infusion pump.
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Subpart C--CARDIOVASCULAR MONITORING DEVICES
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| Biopotential amplifier and signal conditioner.
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| Transducer signal amplifier and conditioner.
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| Cardiovascular blood flowmeter.
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| Extravascular blood flow probe.
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| Cardiac monitor (including cardiotachometer and rate alarm).
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| Apex cardiograph (vibrocardiograph).
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| Electrocardiograph lead switching adaptor.
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| Electrocardiograph electrode.
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| Electrocardiograph surface electrode tester.
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| Medical cathode-ray tube display.
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| Portable leakage current alarm.
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| Impedance plethysmograph.
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| Hydraulic, pneumatic, or photoelectric plethysmographs.
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| Medical magnetic tape recorder.
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| Apex cardiographic transducer.
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| Extravascular blood pressure transducer.
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| Implantable Intra-aneurysm Pressure Measurement System.
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| Catheter tip pressure transducer.
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| Vessel occlusion transducer.
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| Patient transducer and electrode cable (including connector).
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| Radiofrequency physiological signal transmitter and receiver.
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| Telephone electrocardiograph transmitter and receiver.
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Subpart D--CARDIOVASCULAR PROSTHETIC DEVICES
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| Vascular embolization device.
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| Cardiovascular intravascular filter.
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| Vascular graft prosthesis.
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| Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
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| Intra-aortic balloon and control system
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| Ventricular bypass (assist) device.
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| External pacemaker pulse generator.
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| Implantable pacemaker pulse generator.
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| Pacemaker generator function analyzer.
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| Indirect pacemaker generator function analyzer.
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| Pacemaker polymeric mesh bag.
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| Cardiovascular permanent or temporary pacemaker electrode.
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| Pacemaker repair or replacement material.
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| Pacemaker electrode function tester.
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| Carotid sinus nerve stimulator.
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| Prosthetic heart valve holder.
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| Prosthetic heart valve sizer.
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Subpart E--CARDIOVASCULAR SURGICAL DEVICES
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| Endomyocardial biopsy device.
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| Cardiopulmonary bypass accessory equipment.
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| Cardiopulmonary bypass bubble detector.
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| Cardiopulmonary bypass vascular catheter, cannula, or tubing.
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| Cardiopulmonary bypass heart-lung machine console.
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| Cardiopulmonary bypass defoamer.
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| Cardiopulmonary bypass heat exchanger.
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| Cardiopulmonary bypass temperature controller.
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| Cardiopulmonary bypass arterial line blood filter.
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| Cardiopulmonary bypass cardiotomy suction line blood filter.
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| Cardiopulmonary prebypass filter.
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| Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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| Cardiopulmonary bypass gas control unit.
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| Cardiopulmonary bypass coronary pressure gauge.
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| Cardiopulmonary bypass pulsatile flow generator.
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| Cardiopulmonary bypass on-line blood gas monitor.
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| Cardiopulmonary bypass level sensing monitor and/or control.
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| Cardiopulmonary bypass oxygenator.
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| Nonroller-type cardiopulmonary bypass blood pump.
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| Roller-type cardiopulmonary bypass blood pump.
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| Cardiopulmonary bypass pump speed control.
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| Cardiopulmonary bypass pump tubing.
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| Cardiopulmonary bypass blood reservoir.
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| Cardiopulmonary bypass in-line blood gas sensor.
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| Cardiopulmonary bypass cardiotomy return sucker.
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| Cardiopulmonary bypass intracardiac suction control.
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| Cardiovascular surgical instruments.
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| Intraluminal artery stripper.
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Subpart F--CARDIOVASCULAR THERAPEUTIC DEVICES
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| Patient care suction apparatus.
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| External cardiac compressor.
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| External counter-pulsating device.
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| DC-defribrillator (including paddles).
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| Automated external defibrillator.
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| External transcutaneous cardiac pacemaker (noninvasive).
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| Compressible limb sleeve.
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| Thermal regulating system.
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| Automatic rotating tourniquet.
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