21 CFR § 870.4380 Cardiovascular Devices

§ 870.4380 Cardiopulmonary bypass pump speed control.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(a) Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.

(b) Classification. Class II (performance standards).

← § 870.4370 Roller-type cardiopulmonary bypass blood pump.§ 870.4390 Cardiopulmonary bypass pump tubing. →