510(k) K173593 · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 21, 2018 |
| Received | Nov 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173593
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2024 | Fresenius Medical Care Holdings, Inc. stay-safe /Safe Lock Catheter Ext. 12 in Open, Classified |
KDJ | None listed |
| Mar 26, 2024 | Fresenius Medical Care Holdings, Inc. stay-safe /Luer Lock Adapter 4 in Open, Classified |
KDJ | None listed |
| Mar 26, 2024 | Fresenius Medical Care Holdings, Inc. stay-safe /Luer Lock Catheter Ext. 12 in Open, Classified |
KDJ | None listed |
| Mar 26, 2024 | Fresenius Medical Care Holdings, Inc. stay-safe /Luer Lock Catheter Ext. 18 in Open, Classified |
KDJ | None listed |
| Mar 26, 2024 | Fresenius Medical Care Holdings, Inc. stay-safe /Luer Catheter Ext. 6 in Open, Classified |
KDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.