510(k) K231589

Blood Tubing Lines for Hemodialysis AV06C-E by NIKKISO CO., LTD. — Product Code KOC

K231589 is an FDA 510(k) premarket notification submitted by NIKKISO CO., LTD. for the device "Blood Tubing Lines for Hemodialysis AV06C-E". The FDA issued a decision of Substantially Equivalent on July 28, 2023. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. NIKKISO CO., LTD. has at least 10 other 510(k) clearances on record.