CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS

CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS is an FDA 510(k)-cleared medical device (K960755) manufactured by Medtronic Cardiac Surgery, Medtronic, 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 22, 1996. Regulation: 8.