510(k) K253518 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FX CorAL 40; FX CorAL 50
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Dec 18, 2025 |
| Received | Nov 12, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253518
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.