Device type
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product code KDI · Class II · 21 CFR 876.5860 · Gastroenterology, Urology
Recent 510(k)s
Oct 19, 2026
K261203
multiFiltratePRO System
Fresenius Medical Care Renal Therapies Group, LLC
- KDI
- Class II
Recent recalls
Sep 2, 2026
Z-3017-2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC
- KDI
- Class II
- Ongoing