510(k) K811463 ยท FPA Set, Administration, Intravascular
AUTO-SYRINGE MICRO VOLUME EXTENSION SET
| Applicant | Baxter Healthcare Corp, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 12, 1981 |
| Received | May 26, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345; An Rx sterile, nonpyrogenic fluid pathway, 36'', 0.38mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway, 60'', 0.5mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 6 Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349; An Rx sterile, nonpyrogenic fluid pathway, 60', 2.14mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Interlink System Solution Set with Microbore Tubing, 60 Drops/mL, 123'', 2 injection sites, Male Luer Lock Adapter, catalog 2C6426; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.