BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM

BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM is an FDA 510(k)-cleared medical device (K040027) manufactured by Boston Scientific. 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 29, 2004. Regulation: 8.