510(k) K124024 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
APD LUER-LOCK ADAPTER
| Applicant | Fresensius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Sep 19, 2013 |
| Received | Dec 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K124024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) c Terminated |
KDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.