DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML

DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML is an FDA 510(k)-cleared medical device (K030638) manufactured by Avantec Vascular Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 2003. Regulation: 8.