510(k) K242126 ยท FPA Set, Administration, Intravascular
I.V. Administration Set
| Applicant | Bq Plus Medical Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Aug 22, 2024 |
| Received | Jul 19, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Medline Industries, LP Medline Industries IV Administration and Extension Sets:
1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529;
2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029;
3) DBD-IVEX Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.