21 C.F.R. § 870.4380 Cardiopulmonary bypass pump speed control.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4380 Cardiopulmonary bypass pump speed control.
