510(k) K192756 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Aquadex FlexFlow System 2.0
| Applicant | Chf Solutions, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Feb 24, 2020 |
| Received | Sep 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Nuwellis Inc nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System Completed |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.