510(k) K982005

WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS by Boston Scientific Scimed, Inc. — Product Code FGE

K982005 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on September 2, 1998. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.