510(k) K220721 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 11, 2023 |
| Received | Mar 14, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220721
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.