510(k) K811078 ยท FPA Set, Administration, Intravascular
RADIATION STERILIZED ADMIN. SET
| Applicant | Travenol Laboratories, S.A., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 2, 1981 |
| Received | Apr 20, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2013 | Baxter Healthcare Corp. A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only;
B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. Terminated |
FPA | None listed |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP Y-Type Catheter Extension Set, 5.3" (13.5 cm), 1.0 mL, Male Luer Lock Adapter with Retractable Collar; a sterile Rx device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; pro Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Minivolume Extension Set, product code 2C5681; An Rx sterile, nonpyrogenic fluid pathway, 6.4'', 0.4 mL Vol., with male Luer Slip T-Connector; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP I.V. Catheter Extension Set, product code 2N1194; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 0.3 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Mini-Infuser Microbore Extension Set, product code 2C9203; An Rx sterile, nonpyrogenic fluid pathway, 61'', 0.9 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, I Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Minivolume Extension Set, product code 1C8400; An Rx sterile, nonpyrogenic fluid pathway, 13.0'', 0.4 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U. Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP Minivolume Extension Set, product code 1C8690; An Rx sterile, nonpyrogenic fluid pathway, 8'', 0.22 mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60 Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension s Terminated |
FMG | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Y-Type Minivolume Extension Set, product code 1C8689; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 6 Terminated |
FPA | None listed |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18'', 1.3 mL Vol., with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporat Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Y-Type Minivolume Extension Set; catalog 1C8499; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y; Baxter Healthcare Corporation, Auto Syringe Division, Hookset, NH 03106 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522 and 1M8522Y; Baxter Healthcare Corporation, Auto Syringe Division, Hookset, NH 03106 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and 1M8527Y; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter AutoSyringe Extension Set with 0.22 Micron Filter, catalog 1M8529; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5683; Baxter Healthcare Corporation, Deerfield, IL 60015; 48 units per case Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5693; Baxter Healthcare Corporation, Deerfield, IL 60015; 48 units per case Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.