K252377
- 510(k) number
- K252377
- Device name
- NxStage System One with NxView
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2026-05-15
- Date received
- 2025-07-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252377.pdf
Official FDA record: K252377
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.