Finesse™ Injectable PTA Balloon Dilatation Catheter

Finesse™ Injectable PTA Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K230263) manufactured by Summa Therapeutics, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2023. Regulation: 8.