510(k) K243920 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Purema H Hemoconcentrator - Pediatric
| Applicant | Medica USA, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 19, 2025 |
| Received | Dec 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243920
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.