21 C.F.R. § 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
