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Title 21

Displaying title 21, up to date as of 7/09/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 870Cardiovascular Devices870.1 – 870.5925
Subpart ECardiovascular Surgical Devices870.4075 – 870.4885
§ 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.