510(k) K160749

CRIT-LINE III Blood Chamber II by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KOC

K160749 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "CRIT-LINE III Blood Chamber II". The FDA issued a decision of Substantially Equivalent on April 15, 2016. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.