510(k) K243237 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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, Waltham MD, US |
| Decision | Substantially Equivalent, Jun 13, 2025 |
| Received | Oct 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243237
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2026 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130. Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.