Section 870.4350 - Cardiopulmonary bypass oxygenator(a)Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions."45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542 , Apr. 10, 2001