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