21 CFR Subpart E - Cardiovascular Surgical Devices

  1. § 870.4075 Endomyocardial biopsy device.
  2. § 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
  3. § 870.4200 Cardiopulmonary bypass accessory equipment.
  4. § 870.4205 Cardiopulmonary bypass bubble detector.
  5. § 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
  6. § 870.4220 Cardiopulmonary bypass heart-lung machine console.
  7. § 870.4230 Cardiopulmonary bypass defoamer.
  8. § 870.4240 Cardiopulmonary bypass heat exchanger.
  9. § 870.4250 Cardiopulmonary bypass temperature controller.
  10. § 870.4260 Cardiopulmonary bypass arterial line blood filter.
  11. § 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
  12. § 870.4280 Cardiopulmonary prebypass filter.
  13. § 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
  14. § 870.4300 Cardiopulmonary bypass gas control unit.
  15. § 870.4310 Cardiopulmonary bypass coronary pressure gauge.
  16. § 870.4320 Cardiopulmonary bypass pulsatile flow generator.
  17. § 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
  18. § 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
  19. § 870.4350 Cardiopulmonary bypass oxygenator.
  20. § 870.4360 Nonroller-type blood pump.
  21. § 870.4370 Roller-type cardiopulmonary bypass blood pump.
  22. § 870.4380 Cardiopulmonary bypass pump speed control.
  23. § 870.4390 Cardiopulmonary bypass pump tubing.
  24. § 870.4400 Cardiopulmonary bypass blood reservoir.
  25. § 870.4410 Cardiopulmonary bypass in-line blood gas sensor.
  26. § 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
  27. § 870.4430 Cardiopulmonary bypass intracardiac suction control.
  28. § 870.4450 Vascular clamp.
  29. § 870.4475 Surgical vessel dilator.
  30. § 870.4500 Cardiovascular surgical instruments.
  31. § 870.4510 Apical closure device.
  32. § 870.4875 Intraluminal artery stripper.
  33. § 870.4885 External vein stripper.