510(k) K231125 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
2008T BlueStar Hemodialysis Machine
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Dec 6, 2023 |
| Received | Apr 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231125
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Open, Classified |
KDI | None listed |
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Open, Classified |
KDI | None listed |
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Open, Classified |
KDI | None listed |
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.