CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART E—Cardiovascular Surgical Devices (§870.4075 to §870.4885) > 870.4290—Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

870.4290—Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(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).