BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS is an FDA 510(k)-cleared medical device (K925369) manufactured by Sorin Biomedica, Fiat, USA, 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 March 25, 1993. Regulation: 8.