CORDIS OPTA5 PTA BALLOON CATHETER

CORDIS OPTA5 PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K970620) 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 May 5, 1997. Regulation: 8.