CARDIOPLEGIA HEAT EXCHANGER HOLDER

CARDIOPLEGIA HEAT EXCHANGER HOLDER is an FDA 510(k)-cleared medical device (K840256) manufactured by American Bentley. 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 16, 1984. Regulation: 8.