510(k) K905738

OPERATIVE CHOLANGIOGRAPHIC CATHETER by Applied Vascular Devices, Inc. — Product Code FGE

K905738 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "OPERATIVE CHOLANGIOGRAPHIC CATHETER". The FDA issued a decision of Substantially Equivalent on March 21, 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. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.