OMEGA NV(TM) BALLOON DILATATION CATHETER

OMEGA NV(TM) BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K882052) manufactured by Cook, 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 13, 1988. Regulation: 8.