510(k) K070610

SKATER BILIARY CATHETER by Angiotech — Product Code FGE

K070610 is an FDA 510(k) premarket notification submitted by Angiotech for the device "SKATER BILIARY CATHETER". The FDA issued a decision of Substantially Equivalent on June 21, 2007. 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. Angiotech has at least 6 other 510(k) clearances on record.