CARDIOTOMY RESERVOIR-FILTERED & NON

CARDIOTOMY RESERVOIR-FILTERED & NON is an FDA 510(k)-cleared medical device (K830727) manufactured by Electromics, 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 4, 1983. Regulation: 8.