510(k) K024048

MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM by Boston Scientific Scimed, Inc. — Product Code FGE

K024048 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM". The FDA issued a decision of SESU on January 6, 2003. 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.