510(k) K041005 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Oct 7, 2004 |
| Received | Apr 19, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K041005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | None listed |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | None listed |
| Jul 22, 2021 | Baxter Healthcare Corporation Baxter PrismaFlex, REF numbers:
a) 106696 (M 60 SET)
b) 106697 (M 100 SET)
Expansion:
c) 107144 (TPE2000 SET)
d) 115307 (M 150 SET)
e) 115309 (ST 100 SET)
f) 955467 (M 150 SET)
g) 955468 (ST 100 S Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
| Mar 31, 2007 | Gambro Renal Products, Inc. Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden. Terminated |
KDI | None listed |
| Oct 12, 2006 | Gambro Renal Products, Inc. Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.