510(k) K130245 ยท FMG Stopcock, I.V. Set
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Mar 1, 2013 |
| Received | Jan 31, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | Baxter Healthcare Corporation CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255 Open, Classified |
FMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.