510(k) K122546

SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM by Idev Technologies, Inc. — Product Code FGE

K122546 is an FDA 510(k) premarket notification submitted by Idev Technologies, Inc. for the device "SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM". The FDA issued a decision of SESU on December 7, 2012. 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. Idev Technologies, Inc. has at least 10 other 510(k) clearances on record.