510(k) K153158 ยท FPA Set, Administration, Intravascular
Solution Administration Sets with 0.2 Micron Filter
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Dec 28, 2015 |
| Received | Nov 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571 Open, Classified |
FMG | None listed |
| Oct 16, 2025 | Baxter Healthcare Corporation CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593 Open, Classified |
FMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.