21 CFR Subpart E
Cardiovascular Surgical Devices
June 25, 2020
§
870.4250
Cardiopulmonary bypass temperature controller
§
870.4075
Endomyocardial biopsy device
§
870.4260
Cardiopulmonary bypass arterial line blood filter
§
870.4100
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure
§
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
§
870.4270
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