510(k) K072093 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX SYSTEM, VERSION 3.20
| Applicant | Gambro, Lakewood CO, US |
| Decision | Substantially Equivalent, Feb 1, 2008 |
| Received | Jul 30, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072093
| 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 |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | None listed |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | None listed |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | None listed |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | None listed |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | None listed |
| Apr 24, 2018 | Baxter Healthcare Corporation Prismaflex System, Product Code 107493
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 |
| Apr 6, 2011 | Gambro Renal Products, Incorporated Prismaflex System, Catalog Number 107493,
Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.