510(k) K955413

ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER by Endovations — Product Code FGE

K955413 is an FDA 510(k) premarket notification submitted by Endovations for the device "ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on February 8, 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. Endovations has at least 10 other 510(k) clearances on record.