VECTOR PTA BALLOON DILATATION CATHETER

VECTOR PTA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K131329) manufactured by R4 Vascular, 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 June 5, 2013. Regulation: 8.