21 CFR 870.4230
§ 870.4230 Cardiopulmonary bypass defoamer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4230, § 870.4230 Cardiopulmonary bypass defoamer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89991
- Permanent ID
ys:prov:89991@1- SHA-256
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Full text
(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.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.