ComboCath OTW PTA Dilatation Catheter

ComboCath OTW PTA Dilatation Catheter is an FDA 510(k)-cleared medical device (K150452) 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 August 12, 2015. Regulation: 8.