CORDIS OPTA 5(TM), MODIFICATION

CORDIS OPTA 5(TM), MODIFICATION is an FDA 510(k)-cleared medical device (K933236) manufactured by Cordis 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 26, 1993. Regulation: 8.