510(k) K022412 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Mar 5, 2003 |
| Received | Jul 24, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022412
| 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.