510(k) K173363

Cycler Drain Bag Set by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDJ

K173363 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Cycler Drain Bag Set". The FDA issued a decision of Substantially Equivalent on January 24, 2018. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.