CARDIOPULMONARY SUPPORT (CPS) SYSTEM

CARDIOPULMONARY SUPPORT (CPS) SYSTEM is an FDA 510(k)-cleared medical device (K892664) manufactured by Bard Cardiosurgery Div. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 1990. Regulation: 8.