BERMAN ANGIOGRAPHIC BALLOON CATHETER

BERMAN ANGIOGRAPHIC BALLOON CATHETER is an FDA 510(k)-cleared medical device (K822033) manufactured by Ziehm International, 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 August 23, 1982. Regulation: 8.