§870.4350. Cardiopulmonary bypass oxygenator.
21 C.F.R. § 870.4350
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.
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.”
Notes, amendments, and revision history
Amendments
[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.
Amendments
[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001]