Title 21

PART 870 SUBPART E

Subpart E - Cardiovascular Surgical Devices

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
• 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

21:8.0.1.1.22.5.1.1	SECTION 870.4075	870.4075 Endomyocardial biopsy device.
21:8.0.1.1.22.5.1.2	SECTION 870.4100	870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
21:8.0.1.1.22.5.1.3	SECTION 870.4200	870.4200 Cardiopulmonary bypass accessory equipment.
21:8.0.1.1.22.5.1.4	SECTION 870.4205	870.4205 Cardiopulmonary bypass bubble detector.
21:8.0.1.1.22.5.1.5	SECTION 870.4210	870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
21:8.0.1.1.22.5.1.6	SECTION 870.4220	870.4220 Cardiopulmonary bypass heart-lung machine console.
21:8.0.1.1.22.5.1.7	SECTION 870.4230	870.4230 Cardiopulmonary bypass defoamer.
21:8.0.1.1.22.5.1.8	SECTION 870.4240	870.4240 Cardiopulmonary bypass heat exchanger.
21:8.0.1.1.22.5.1.9	SECTION 870.4250	870.4250 Cardiopulmonary bypass temperature controller.
21:8.0.1.1.22.5.1.10	SECTION 870.4260	870.4260 Cardiopulmonary bypass arterial line blood filter.
21:8.0.1.1.22.5.1.11	SECTION 870.4270	870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
21:8.0.1.1.22.5.1.12	SECTION 870.4280	870.4280 Cardiopulmonary prebypass filter.
21:8.0.1.1.22.5.1.13	SECTION 870.4290	870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
21:8.0.1.1.22.5.1.14	SECTION 870.4300	870.4300 Cardiopulmonary bypass gas control unit.
21:8.0.1.1.22.5.1.15	SECTION 870.4310	870.4310 Cardiopulmonary bypass coronary pressure gauge.
21:8.0.1.1.22.5.1.16	SECTION 870.4320	870.4320 Cardiopulmonary bypass pulsatile flow generator.
21:8.0.1.1.22.5.1.17	SECTION 870.4330	870.4330 Cardiopulmonary bypass on-line blood gas monitor.
21:8.0.1.1.22.5.1.18	SECTION 870.4340	870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
21:8.0.1.1.22.5.1.19	SECTION 870.4350	870.4350 Cardiopulmonary bypass oxygenator.
21:8.0.1.1.22.5.1.20	SECTION 870.4360	870.4360 Nonroller-type blood pump.
21:8.0.1.1.22.5.1.21	SECTION 870.4370	870.4370 Roller-type cardiopulmonary bypass blood pump.
21:8.0.1.1.22.5.1.22	SECTION 870.4380	870.4380 Cardiopulmonary bypass pump speed control.
21:8.0.1.1.22.5.1.23	SECTION 870.4390	870.4390 Cardiopulmonary bypass pump tubing.
21:8.0.1.1.22.5.1.24	SECTION 870.4400	870.4400 Cardiopulmonary bypass blood reservoir.
21:8.0.1.1.22.5.1.25	SECTION 870.4410	870.4410 Cardiopulmonary bypass in-line blood gas sensor.
21:8.0.1.1.22.5.1.26	SECTION 870.4420	870.4420 Cardiopulmonary bypass cardiotomy return sucker.
21:8.0.1.1.22.5.1.27	SECTION 870.4430	870.4430 Cardiopulmonary bypass intracardiac suction control.
21:8.0.1.1.22.5.1.28	SECTION 870.4450	870.4450 Vascular clamp.
21:8.0.1.1.22.5.1.29	SECTION 870.4475	870.4475 Surgical vessel dilator.
21:8.0.1.1.22.5.1.30	SECTION 870.4500	870.4500 Cardiovascular surgical instruments.
21:8.0.1.1.22.5.1.31	SECTION 870.4510	870.4510 Apical closure device.
21:8.0.1.1.22.5.1.32	SECTION 870.4875	870.4875 Intraluminal artery stripper.
21:8.0.1.1.22.5.1.33	SECTION 870.4885	870.4885 External vein stripper.

---