CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART E—Cardiovascular Surgical Devices (§870.4075 to §870.4885) > 870.4400—Cardiopulmonary bypass blood reservoir.

870.4400—Cardiopulmonary bypass blood reservoir.

(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.