510(k) K003225 ยท FPA Set, Administration, Intravascular
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Oct 19, 2000 |
| Received | Oct 16, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.5" (16.5 cm), Vol 1.2 mL, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Terminated |
FPA | None listed |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Catheter Extension Set, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter, Volume 1.0 mL, Length 6" (15 cm); an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Mar 14, 2007 | Baxter Healthcare Corp. Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, Luer activated valve, Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N8371; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 1.0 mL Vol., with 2 Luer Activated Valves and a male Luer Lock ad Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8705; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 0.33 mL Vol., with Luer Activated Valve for IV Access and male Luer Lo Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8739; An Rx sterile, nonpyrogenic fluid pathway, 8.0'', 0.6 mL Vol., with Luer Activated Valve for IV Access and male Luer Loc Terminated |
FPA | None listed |
| May 17, 2005 | Baxter Healthcare Corp. Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless Terminated |
FPA | None listed |
| Nov 16, 2004 | Baxter Healthcare Corp. Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows the administration Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Clearlink System Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C8519; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Clearlink System Nitroglycerin Set with DUO-VENT Spike, 60 drops/mL, 105'', PVC Tubing Segment, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8851; Baxter Healthcare Corporation, Deerfield, Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111'', Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.22 Micron Extended Life Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Continu-Flo Solution Set, 60 drops/mL, 106'', 3 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C9906; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8750; Baxter Healthcare Corpora Terminated |
KSB | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Baxter Solution Set, 10 drops/mL, 76'', Luer Activated Valve, Male Luer Lock Adapter, catalog 2C9901; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Baxter Solution Set, 60 drops/mL, 76'', Luer Activated Valve, Male Luer Lock Adapter, catalog 2C9902; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Vented Solution Set, 10 drops/mL, 92'', Luer Activated Valve, Male Luer Lock Adapter, catalog 2C9903; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Continu-Flo Solution Set, 10 drops/mL, 110'', 3 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C9905; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C9907; 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.