BRAUN PTA BALLOON CATHETER

BRAUN PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K951248) manufactured by B.Braun Medical, 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 June 21, 1995. Regulation: 8.