510(k) K131516 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX SYSTEM 7.10
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jan 3, 2014 |
| Received | May 28, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131516
| 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 |
| Apr 7, 2020 | Baxter Healthcare Corporation Prismaflex Control Unit Terminated |
KDI | None listed |
| Apr 24, 2018 | Baxter Healthcare Corporation Prismaflex 7.XX US, Product Code 115269
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 24, 2018 | Baxter Healthcare Corporation Prismaflex 7.20 US, Product Code 955542
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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.