MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)

MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) is an FDA 510(k)-cleared medical device (K022042) manufactured by Cardeon Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 2002. Regulation: 8.