21 C.F.R. § 870.4380

Current through October 31, 2024
Section 870.4380 - Cardiopulmonary bypass pump speed control
(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).

21 C.F.R. § 870.4380