510(k) K912288

WILTEK STANDARD CHOLANGIOGRAPHY CATHETER by Wiltek Medical, Inc. — Product Code FGE

K912288 is an FDA 510(k) premarket notification submitted by Wiltek Medical, Inc. for the device "WILTEK STANDARD CHOLANGIOGRAPHY CATHETER". The FDA issued a decision of Substantially Equivalent on September 23, 1991. 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. Wiltek Medical, Inc. has at least 10 other 510(k) clearances on record.