510(k) K033393

ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM by Guidant Corp. — Product Code FGE

K033393 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM". The FDA issued a decision of SESU on November 10, 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. Guidant Corp. has at least 10 other 510(k) clearances on record.