510(k) K103832 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PHOENIX HEMODIALYSIS DELIVERY SYSTEM
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, May 20, 2011 |
| Received | Dec 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2017 | Baxter Healthcare Corporation Maintenance Kit PH1, Cod. 6997266
The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighin Terminated |
KDI | None listed |
| Jan 4, 2017 | Baxter Healthcare Corporation Maintenance Kit PH2, Cod. 6997274
The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighin Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.