510(k) K173651 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Feb 14, 2018 |
| Received | Nov 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chron Terminated |
KDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.