510(k) K213639 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Revaclear 500, Revaclear 400, Revaclear 300
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Jan 24, 2022 |
| Received | Nov 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213639
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.