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Electronic Code of Federal Regulations

e-CFR data is current as of April 8, 2020

Title 21Chapter ISubchapter HPart 870Subpart E → §870.4210


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices


§870.4210   Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(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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