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) > 870.4230—Cardiopulmonary bypass defoamer.

870.4230—Cardiopulmonary bypass defoamer.

(a) Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.
(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”

Code of Federal Regulations

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001]