21 CFR § 870.4380 - Cardiopulmonary bypass pump speed control.

§ 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).