510(k) K152953

CRIT-LINE CLIP (CLIC) BLOOD CHAMBER by Fresenius Medical Care North America — Product Code KOC

K152953 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "CRIT-LINE CLIP (CLIC) BLOOD CHAMBER". The FDA issued a decision of Substantially Equivalent on November 5, 2015. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.