510(k) K141997

CRIT-LINE IV SYSTEM by Fresenius Medical Care — Product Code KOC

K141997 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care for the device "CRIT-LINE IV SYSTEM". The FDA issued a decision of Substantially Equivalent on April 1, 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 has at least 6 other 510(k) clearances on record.