§ 870.4210. Cardiopulmonary bypass vascular catheter, cannula, or tubing.
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/us/cfr/t21/s§ 870.4210·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).