510(k) K250508 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
AK 98 Dialysis Machine (955607)
| Applicant | Vantive US Healthcare, LLC, Deerfield Lake IL, US |
| Decision | Substantially Equivalent, Aug 1, 2025 |
| Received | Feb 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250508
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.