510(k) K110823 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jun 17, 2011 |
| Received | Mar 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110823
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2021 | Baxter Healthcare Corporation Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). Terminated |
KDI | None listed |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | None listed |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | None listed |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | None listed |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | None listed |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | None listed |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | None listed |
| Apr 24, 2018 | Baxter Healthcare Corporation Prismaflex 5.10 US, Product Code 113081
Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute Terminated |
KDI | None listed |
| Feb 15, 2017 | Baxter Healthcare Corporation Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system.
Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.