Title 21

SECTION 870.4380

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).