510(k) K013737

MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON by Telemed Systems, Inc. — Product Code FGE

K013737 is an FDA 510(k) premarket notification submitted by Telemed Systems, Inc. for the device "MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON". The FDA issued a decision of Substantially Equivalent on March 1, 2002. 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. Telemed Systems, Inc. has at least 10 other 510(k) clearances on record.