510(k) K021824

DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 by Guidant Corp. — Product Code FGE

K021824 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010". The FDA issued a decision of SESU on July 2, 2002. 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.