510(k) K955277

ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS by Baxter Healthcare Corp — Product Code KOC

K955277 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on Feb 16, 1996. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.