510(k) K072720

ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM by Alveolus, Inc. — Product Code FGE

K072720 is an FDA 510(k) premarket notification submitted by Alveolus, Inc. for the device "ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM". The FDA issued a decision of SESU on April 11, 2008. 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. Alveolus, Inc. has at least 10 other 510(k) clearances on record.