510(k) K791496 ยท FPA Set, Administration, Intravascular
LOW PLASTICIZER ADMINISTRATION SETS
| Applicant | Travenol Laboratories, S.A., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 8, 1980 |
| Received | Aug 3, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K791496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP Y-Type Catheter Extension Set, product code 2N1191; An Rx sterile, nonpyrogenic fluid pathway, 4.8', 0.6 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, 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 |
| 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 Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FPA | None listed |
| Jun 1, 2005 | Baxter Healthcare Corp. Baxter Extension Sets with PosiFlow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with PosiFlow Positive Displa 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 |
| Apr 8, 2005 | Baxter Healthcare Corp. Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with Posiflow Positive Displa 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 |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Microbore 3-Lead Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3342; Baxter Healthcare Corporation, Deerfield, IL 60015; 50 units per case Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter 36'' Micro-Volume Extension Set, catalog 2N3347; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.