Title 21, Part 870 — Cardiovascular Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Arrhythmia detector and alarm (including ST-segment measurement and alarm).

Blood pressure alarm.

Blood pressure computer.

Blood pressure cuff.

Noninvasive blood pressure measurement system.

Venous blood pressure manometer.

Diagnostic intravascular catheter.

Continuous flush catheter.

Electrode recording catheter or electrode recording probe.

Fiberoptic oximeter catheter.

Flow-directed catheter.

Percutaneous catheter.

Temporary catheter for embolic protection during transcatheter intracardiac procedures.

Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.

Balloon aortic valvuloplasty catheter.

Intracavitary phonocatheter system.

Steerable catheter.

Steerable catheter control system.

Catheter cannula.

Vessel dilator for percutaneous catheterization.

Catheter guide wire.

Catheter introducer.

Reverse central venous recanalization system.

Intravascular bleed monitor.

Catheter balloon repair kit.

Trace microsphere.

Catheter tip occluder.

Catheter stylet.

Trocar.

Interventional cardiovascular implant simulation software device.

Coronary vascular physiologic simulation software device.

Coronary artery disease risk indicator using acoustic heart signals.

Programmable diagnostic computer.

Single-function, preprogrammed diagnostic computer.

Densitometer.

Angiographic injector and syringe.

Indicator injector.

Syringe actuator for an injector.

External programmable pacemaker pulse generator.

Withdrawal-infusion pump.

Stethoscope.

Thermodilution probe.

Biopotential amplifier and signal conditioner.

Transducer signal amplifier and conditioner.

Cardiovascular blood flowmeter.

Extravascular blood flow probe.

Adjunctive cardiovascular status indicator.

Adjunctive predictive cardiovascular indicator.

Adjunctive hemodynamic indicator with decision point.

Cardiac monitor (including cardiotachometer and rate alarm).

Apex cardiograph (vibrocardiograph).

Ballistocardiograph.

Echocardiograph.

Electrocardiograph.

Electrocardiograph software for over-the-counter use.

Electrocardiograph lead switching adaptor.

Electrocardiograph electrode.

Electrocardiograph surface electrode tester.

Phonocardiograph.

Vectorcardiograph.

Medical cathode-ray tube display.

Signal isolation system.

Line isolation monitor.

Portable leakage current alarm.

Oscillometer.

Oximeter.

Ear oximeter.

Impedance phlebograph.

Impedance plethysmograph.

Hydraulic, pneumatic, or photoelectric plethysmographs.

Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

Photoplethysmograph analysis software for over-the-counter use.

Medical magnetic tape recorder.

Paper chart recorder.

Apex cardiographic transducer.

Extravascular blood pressure transducer.

Implantable Intra-aneurysm Pressure Measurement System.

Heart sound transducer.

Catheter tip pressure transducer.

Ultrasonic transducer.

Vessel occlusion transducer.

Patient transducer and electrode cable (including connector).

Radiofrequency physiological signal transmitter and receiver.

Telephone electrocardiograph transmitter and receiver.

Vascular clip.

Vena cava clip.

Vascular embolization device.

Cardiovascular intravascular filter.

Vascular graft prosthesis.

Endovascular Suturing System.

Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

Intra-aortic balloon and control system.

Ventricular bypass (assist) device.

External pacemaker pulse generator.

Pacing system analyzer.

Implantable pacemaker pulse generator.

Pacemaker lead adaptor.

Pacemaker generator function analyzer.

Indirect pacemaker generator function analyzer.

Pacemaker polymeric mesh bag.

Pacemaker charger.

Cardiovascular permanent or temporary pacemaker electrode.

Pacemaker test magnet.

Pacemaker programmers.

Pacemaker repair or replacement material.

Pacemaker electrode function tester.

Pacemaker service tools.

Annuloplasty ring.

Carotid sinus nerve stimulator.

Replacement heart valve.

Prosthetic heart valve holder.

Prosthetic heart valve sizer.

Endomyocardial biopsy device.

Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.

Extracorporeal system for carbon dioxide removal.

Cardiopulmonary bypass accessory equipment.

Cardiopulmonary bypass bubble detector.

Cardiopulmonary bypass vascular catheter, cannula, or tubing.

Cardiopulmonary bypass heart-lung machine console.

Cardiopulmonary bypass defoamer.

Cardiopulmonary bypass heat exchanger.

Cardiopulmonary bypass temperature controller.

Cardiopulmonary bypass arterial line blood filter.

Cardiopulmonary bypass cardiotomy suction line blood filter.

Cardiopulmonary prebypass filter.

Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Cardiopulmonary bypass gas control unit.

Cardiopulmonary bypass coronary pressure gauge.

Cardiopulmonary bypass pulsatile flow generator.

Cardiopulmonary bypass on-line blood gas monitor.

Cardiopulmonary bypass level sensing monitor and/or control.

Cardiopulmonary bypass oxygenator.

Nonroller-type blood pump.

Roller-type cardiopulmonary bypass blood pump.

Cardiopulmonary bypass pump speed control.

Cardiopulmonary bypass pump tubing.

Cardiopulmonary bypass blood reservoir.

Cardiopulmonary bypass in-line blood gas sensor.

Cardiopulmonary bypass cardiotomy return sucker.

Cardiopulmonary bypass intracardiac suction control.

Vascular clamp.

Surgical vessel dilator.

Cardiovascular surgical instruments.

Apical closure device.

Intraluminal artery stripper.

External vein stripper.

Patient care suction apparatus.

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

Embolectomy catheter.

Septostomy catheter.

External cardiac compressor.

Cardiopulmonary resuscitation (CPR) aid.

External counter-pulsating device.

DC-defibrillator (including paddles).

Automated external defibrillator system.

Defibrillator tester.

External transcutaneous cardiac pacemaker (noninvasive).

Adjunctive open loop fluid therapy recommender.

Steerable cardiac ablation catheter remote control system.

Compressible limb sleeve.

Thermal regulating system.

Esophageal thermal regulation device.

Automatic rotating tourniquet.