510(k) K053459

OMNILINK .035 BILIARY STENT SYSTEM by Guidant Corporation — Product Code FGE

K053459 is an FDA 510(k) premarket notification submitted by Guidant Corporation for the device "OMNILINK .035 BILIARY STENT SYSTEM". The FDA issued a decision of SESU on April 12, 2006. 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 Corporation has at least 10 other 510(k) clearances on record.