CORDIS MAXI DS PTA BALLOON CATHETER

CORDIS MAXI DS PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K991811) 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 June 14, 1999. Regulation: 8.