510(k) K082719

NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P by NIKKISO CO., LTD. — Product Code KOC

K082719 is an FDA 510(k) premarket notification submitted by NIKKISO CO., LTD. for the device "NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P". The FDA issued a decision of Substantially Equivalent on March 30, 2009. 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.