510(k) K834468

DRAINAGE STENT by Microvasive — Product Code FGE

K834468 is an FDA 510(k) premarket notification submitted by Microvasive for the device "DRAINAGE STENT". The FDA issued a decision of Substantially Equivalent on April 20, 1984. 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. Microvasive has at least 10 other 510(k) clearances on record.