STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER

STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K141112) 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 July 15, 2014. Regulation: 8.