21 CFR 870.4210
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4210, § 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89989
- Permanent ID
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Full text
(a) Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.