TRANSLUMINAL BALLOON DILATATION CATHETER

TRANSLUMINAL BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K993305) 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 9, 2000. Regulation: 8.