510(k) K905707

BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS by Baxter Healthcare Corp — Product Code FGE

K905707 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS". The FDA issued a decision of Substantially Equivalent on Feb 13, 1991. 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. Baxter Healthcare Corp has 507 other 510(k) clearances on record.