21 C.F.R. § 870.4430 Cardiopulmonary bypass intracardiac suction control.
Title 21 - Food and Drugs
(a) Identification. A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4430 Cardiopulmonary bypass intracardiac suction control.