UltraScore Focused Force PTA Balloon

UltraScore Focused Force PTA Balloon is an FDA 510(k)-cleared medical device (K163420) 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 June 13, 2017. Regulation: 8.