K252459
- 510(k) number
- K252459
- Device name
- multiFlux 130 (F00013123); multiFlux 160 (F00013124)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2026-02-10
- Date received
- 2025-08-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252459.pdf
Official FDA record: K252459
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.