510(k) K171671 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Prismaflex System 8.10
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Feb 23, 2018 |
| Received | Jun 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171671
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.