MODIFICATION TO CARDEON AEGIS CATHETER

MODIFICATION TO CARDEON AEGIS CATHETER is an FDA 510(k)-cleared medical device (K024058) 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 December 29, 2002. Regulation: 8.