510(k) K071646

SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 by Idev Technologies, Inc. — Product Code FGE

K071646 is an FDA 510(k) premarket notification submitted by Idev Technologies, Inc. for the device "SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120". The FDA issued a decision of SESU on January 31, 2008. 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.