CLEAR CARDIOPLEJIA DELIVERY SYSTEM

CLEAR CARDIOPLEJIA DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K823451) manufactured by 3M Health Care, Sarns. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 1983. Regulation: 8.