Cardiopulmonary bypass vascular catheter, cannula, or tubing.

21 C.F.R. § 870.4210
in effectEffective: 2024-07-01
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(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).

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21 C.F.R. § 870.4210 — Cardiopulmonary bypass vascular catheter, cannula, or tubing | Code of Federal Regulations | Corpus