21 CFR Subpart B - Cardiovascular Diagnostic Devices

  1. § 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
  2. § 870.1100 Blood pressure alarm.
  3. § 870.1110 Blood pressure computer.
  4. § 870.1120 Blood pressure cuff.
  5. § 870.1130 Noninvasive blood pressure measurement system.
  6. § 870.1140 Venous blood pressure manometer.
  7. § 870.1200 Diagnostic intravascular catheter.
  8. § 870.1210 Continuous flush catheter.
  9. § 870.1220 Electrode recording catheter or electrode recording probe.
  10. § 870.1230 Fiberoptic oximeter catheter.
  11. § 870.1240 Flow-directed catheter.
  12. § 870.1250 Percutaneous catheter.
  13. § 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
  14. § 870.1255 Balloon aortic valvuloplasty catheter.
  15. § 870.1270 Intracavitary phonocatheter system.
  16. § 870.1280 Steerable catheter.
  17. § 870.1290 Steerable catheter control system.
  18. § 870.1300 Catheter cannula.
  19. § 870.1310 Vessel dilator for percutaneous catheterization.
  20. § 870.1330 Catheter guide wire.
  21. § 870.1340 Catheter introducer.
  22. § 870.1350 Catheter balloon repair kit.
  23. § 870.1360 Trace microsphere.
  24. § 870.1370 Catheter tip occluder.
  25. § 870.1380 Catheter stylet.
  26. § 870.1390 Trocar.
  27. § 870.1415 Coronary vascular physiologic simulation software device.
  28. § 870.1425 Programmable diagnostic computer.
  29. § 870.1435 Single-function, preprogrammed diagnostic computer.
  30. § 870.1450 Densitometer.
  31. § 870.1650 Angiographic injector and syringe.
  32. § 870.1660 Indicator injector.
  33. § 870.1670 Syringe actuator for an injector.
  34. § 870.1750 External programmable pacemaker pulse generator.
  35. § 870.1800 Withdrawal-infusion pump.
  36. § 870.1875 Stethoscope.
  37. § 870.1915 Thermodilution probe.