K243237
- 510(k) number
- K243237
- Device name
- 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MD · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2025-06-13
- Date received
- 2024-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243237.pdf
Official FDA record: K243237
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.