CHOCOLATE PTCA BOLLOON CATHETER

CHOCOLATE PTCA BOLLOON CATHETER is an FDA 510(k)-cleared medical device (K133633) manufactured by Trireme Medical, Inc.. 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 1, 2014. Regulation: 8.