K243874
- 510(k) number
- K243874
- Device name
- FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2025-02-28
- Date received
- 2024-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243874.pdf
Official FDA record: K243874
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.