K243505
- 510(k) number
- K243505
- Device name
- 5008X Hemodialysis System
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2025-05-30
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K243505.pdf
Official FDA record: K243505
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.