NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS

NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS is an FDA 510(k)-cleared medical device (K934847) 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 April 14, 1994. Regulation: 8.