510(k) DEN190042 ยท QAX Hemodialyzer With Expanded Solute Removal Profile
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Unknown, Aug 28, 2020 |
| Received | Sep 16, 2019 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN190042
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.