---
kind: "section"
citation: "21 C.F.R. § 870.4350"
title: "21"
number: "870.4350"
heading: "Cardiopulmonary bypass oxygenator."
url: "https://uscodex.org/cfr/21/870.4350"
---

# §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.”

## Notes

### 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]