510(k) K203609 ยท FPA Set, Administration, Intravascular
Intravascular Administration Sets
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Sep 30, 2021 |
| Received | Dec 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203609
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519 Open, Classified |
FMG | None listed |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537 Open, Classified |
FMG | None listed |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541 Open, Classified |
FMG | None listed |
| Sep 19, 2025 | Baxter Healthcare Corporation Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set Open, Classified |
FPA | None listed |
| Jan 22, 2025 | Baxter Healthcare Corporation Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.