21 CFR § 870.4350 - Cardiopulmonary bypass oxygenator.

---
identifier: "/us/cfr/t21/s870.4350"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.4350 - Cardiopulmonary bypass oxygenator."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.4350"
section_name: "Cardiopulmonary bypass oxygenator."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "870"
part_name: "CARDIOVASCULAR DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 7907, Feb. 5, 1980, unless otherwise noted."
cfr_part: "870"
---


# 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]