DURAMAX .018 BILIARY STENT SYSTEM

DURAMAX .018 BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K032436) 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 February 3, 2004. Regulation: 8.