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) > 870.4360—Nonroller-type cardiopulmonary bypass blood pump.

870.4360—Nonroller-type cardiopulmonary bypass blood pump.

(a) Identification. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 870.3.

Code of Federal Regulations

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]