510(k) K213992

CombiSet Hemodialysis Blood Tubing Set by Fresenius Medical Care Renal Therapies Group, LLC — Product Code FJK

K213992 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "CombiSet Hemodialysis Blood Tubing Set". The FDA issued a decision of Substantially Equivalent on May 31, 2023. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), 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.