Ultraverse 035 PTA Balloon Dilatation Catheter

Ultraverse 035 PTA Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K142261) manufactured by Bard Peripheral 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 September 23, 2014. Regulation: 8.