Finesse Injectable™ PTA Balloon Dilatation Catheter

Finesse Injectable™ PTA Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K241740) manufactured by Summa Therapeutics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2024. Regulation: 8.