Chocolate XD PTCA Balloon Catheter

Chocolate XD PTCA Balloon Catheter is an FDA 510(k)-cleared medical device (K153682) manufactured by Trireme Medical, 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 June 22, 2016. Regulation: 8.