SUCKER CARDIOTOMY RETURN, C.P. BYPASS

SUCKER CARDIOTOMY RETURN, C.P. BYPASS is an FDA 510(k)-cleared medical device (K812455) manufactured by Electromedics, 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 October 22, 1981. Regulation: 8.