VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT

VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT is an FDA 510(k)-cleared medical device (K964907) 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 August 20, 1997. Regulation: 8.