SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS

SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS is an FDA 510(k)-cleared medical device (K936183) 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 March 22, 1994. Regulation: 8.