AVE ALLIANCE DILATATION CATHETER

AVE ALLIANCE DILATATION CATHETER is an FDA 510(k)-cleared medical device (K931384) manufactured by Applied Vascular Engineering, Inc.. 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 16, 1993. Regulation: 8.