510(k) K243529 ยท FPA Set, Administration, Intravascular
Solution Administration Sets
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Mar 14, 2025 |
| Received | Nov 14, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2026 | Baxter Healthcare Corporation Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.