510(k) K896504

PORGES 2-WAY BALLOON EXTRACTION CATHETER by Porges Corp. — Product Code FGE

K896504 is an FDA 510(k) premarket notification submitted by Porges Corp. for the device "PORGES 2-WAY BALLOON EXTRACTION CATHETER". The FDA issued a decision of Substantially Equivalent on January 26, 1990. 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. Porges Corp. has at least 10 other 510(k) clearances on record.