GLADIATOR ELITE PTA BALLOON DILATATION CATHETER

GLADIATOR ELITE PTA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K132810) 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 February 27, 2014. Regulation: 8.