510(k) K080519 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX M150 SET
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jun 13, 2008 |
| Received | Feb 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | None listed |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.