510(k) K913627 ยท FPA Set, Administration, Intravascular
3 PORT ADAPTER
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Sep 23, 1991 |
| Received | Aug 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913627
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Clearlink System Non-DEHP 3 Port Adapter, 1.2 mL, 2 Luer Activated Valves for IV Access, Male Luer Lock Adapter; a sterile Rx device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; pro Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.