BIPORE BALLOON DILATATION CATHETER

BIPORE BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K973563) manufactured by Bipore, 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 March 31, 1998. Regulation: 8.