510(k) K171652 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Liberty Select Cycler
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Sep 15, 2017 |
| Received | Jun 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171652
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2020 | Fresenius Medical Care Holdings, Inc. Liberty Select Cycler
Software Version 2.9.0
Model Number 180343 and RTLR180343 Completed |
FKX | None listed |
| Jan 24, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343
Product Usage:
The device is indicated for acute and chronic peritoneal dialysis. Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.