510(k) K954713

DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) by Ideas For Medicine, Inc. — Product Code FGE

K954713 is an FDA 510(k) premarket notification submitted by Ideas For Medicine, Inc. for the device "DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on July 24, 1996. 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. Ideas For Medicine, Inc. has at least 10 other 510(k) clearances on record.