510(k) K242053 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Mar 21, 2025 |
| Received | Jul 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242053
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.