MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR

MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR is an FDA 510(k)-cleared medical device (K855049) manufactured by Scimed Life Systems, 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 February 25, 1986. Regulation: 8.