510(k) K213992 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
CombiSet Hemodialysis Blood Tubing Set
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 31, 2023 |
| Received | Dec 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213992
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Fresenius Medical Care Renal Therapies Group, LLC CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors;
Model Number: 03-2522-1; Open, Classified |
FJK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.