CHARGER BALLOON DILATATION CATHETER

CHARGER BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K112701) manufactured by Boston Scientific. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2011. Regulation: 8.