21 C.F.R. § 870.4400 Cardiopulmonary bypass blood reservoir.
Title 21 - Food and Drugs
(a) Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation. (b) Classification. Class II (performance standards), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter.
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4400 Cardiopulmonary bypass blood reservoir.
