510(k) K261399 · QAX Hemodialyzer With Expanded Solute Removal Profile
ELISIO-HX
| Applicant | Nipro Medical Corporation, Miami FL, US |
| Decision | Substantially Equivalent, Jul 28, 2026 |
| Received | Apr 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261399
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.