510(k) K190459

Hemoflow F3 and F4 Dialyzers by Fresenius Medical Care Renal Therapies Group, LLC — Product Code FJI

K190459 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Hemoflow F3 and F4 Dialyzers". The FDA issued a decision of Substantially Equivalent on August 23, 2019. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), 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.