510(k) K243264 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
| Applicant | Sorin Group Italia S.R.L., Mirandola ( Modena), IT |
| Decision | Substantially Equivalent, Apr 25, 2025 |
| Received | Oct 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243264
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.