SMALL VESSEL BALLOON DILATATION CATHETER

SMALL VESSEL BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K897124) 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 July 16, 1990. Regulation: 8.