510(k) K173718 ยท FKX System, Peritoneal, Automatic Delivery
Liberty Cycler Set
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 1, 2018 |
| Received | Dec 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2019 | Fresenius Medical Care Renal Therapies Group, LLC Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows:
(1) LIBERTY Line Cycler Set with Sta Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.