SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM

SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM is an FDA 510(k)-cleared medical device (K030409) manufactured by Cordis 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 March 9, 2003. Regulation: 8.