CHARGER PTA BALLON DILATATION CATHETER

CHARGER PTA BALLON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K112697) manufactured by Boston Scientific. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 29, 2011. Regulation: 8.