510(k) K261267 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Careflux H60;Careflux H70;Careflux V500
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Apr 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261267
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.