21 C.F.R. § 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Title 21 - Food and Drugs
(a) Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.