RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER

RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K130911) manufactured by Ev3, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2013. Regulation: 8.