510(k) K855142

ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY by Angiomed U.S., Inc. — Product Code FGE

K855142 is an FDA 510(k) premarket notification submitted by Angiomed U.S., Inc. for the device "ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY". The FDA issued a decision of Substantially Equivalent on March 11, 1986. 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. Angiomed U.S., Inc. has at least 10 other 510(k) clearances on record.