INTERSEPT CARDIOTOMY RESERVOIR/FILTER

INTERSEPT CARDIOTOMY RESERVOIR/FILTER is an FDA 510(k)-cleared medical device (K813205) manufactured by Extracorporeal Medical Specialities, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on January 27, 1982. Regulation: 8.