MCR4000 & MCR4000F CARDIOTOMY RESERVOIR

MCR4000 & MCR4000F CARDIOTOMY RESERVOIR is an FDA 510(k)-cleared medical device (K902355) manufactured by Medtronic Vascular. 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 22, 1990. Regulation: 8.