DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR

DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR is an FDA 510(k)-cleared medical device (K884872) manufactured by Shiley, Inc.. 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 29, 1989. Regulation: 8.