DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063

DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 is an FDA 510(k)-cleared medical device (K945065) manufactured by Sorin Biomedical, 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 May 18, 1995. Regulation: 8.