510(k) K925126 ยท FPA Set, Administration, Intravascular
INTERLINK(TM) INJECTION SITE
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Jun 18, 1993 |
| Received | Oct 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2013 | Baxter Healthcare Corp. A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only
Product Usage:
This device is indicated for use in bl Terminated |
FPA | None listed |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the Terminated |
FPA | None listed |
| Jul 15, 2011 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per cas Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a male Luer Lock adapt Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 1.0 mL Vol., with 1 Interlink T-connector injection sites and male Luer Lock Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.5 mL Vol., with injection site and male Luer Lock adapter with Re Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter Health Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.6 mL Vol., with injection site and male Luer Lock adapter; Baxter Healthcare Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8412; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstream High Pressure Exte Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7'', 0.3 mL Vol, with Male Luer Slip T-Connector; Baxter Healthcare Corporation, Deerf Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.8 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter H Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Terminated |
FPA | None listed |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A Terminated |
FPA | None listed |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 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 |
| Aug 21, 2003 | Baxter Healthcare Corp. Interlink System Vented Nitroglycerin Set, 104 '', PVC Tubing Segment, Injection Site, Male Luer Lock Adapter, catalog 2C7551; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', 170 to 260 Micron Filter,Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C6723; Baxter Healthca Terminated |
KSB | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set; catalog 1C8412; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set; catalog 1C8483; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Extension Set with 0.22 Micron Filter, catalog 1C8546, Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set with 0.22 Micron Filter, catalog 1C8577, Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3332; Baxter Healthcare Corporation, Deerfield, IL 60015; 200 units per case Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3333; Baxter Healthcare Corporation, Deerfield, IL 60015; 200 units per case Terminated |
FPA | None listed |
| Jan 16, 2003 | Baxter Healthcare Corp. Y-Type Blood/Solution Set, catalog #1C8372; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, 2 Injection Sites, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corp Terminated |
KSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.