MEDI-TECH BALLOON DILATATION CATHETER

MEDI-TECH BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K910995) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 8, 1991. Regulation: 8.