ULTRASCORE Focused Force PTA Balloon

ULTRASCORE Focused Force PTA Balloon is an FDA 510(k)-cleared medical device (K172571) manufactured by C. R. Bard. 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 21, 2017. Regulation: 8.