510(k) clearance
multiFiltratePRO System
- 510(k) number
- K261203
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision date
- Oct 19, 2026
- Date received
- Apr 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KDI
- Device type
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II
- Regulation
- 21 CFR 876.5860
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Waltham, MA, US