NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER

NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER is an FDA 510(k)-cleared medical device (K132777) 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 September 25, 2013. Regulation: 8.