510(k) K964850 ยท FPA Set, Administration, Intravascular
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Feb 25, 1997 |
| Received | Dec 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964850
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 1C8483; An Rx sterile, nonpyrogenic fluid pathway, 18', 1.3 mL Vol. with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer 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 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16'', 4.2 mL Vol., with 0.22 Micron Downstream High Pressure Extended Life Filter, 2 injection sites and a male Luer Lock adapter Terminated |
FPA | None listed |
| Aug 21, 2003 | Baxter Healthcare Corp. Continu-Flo Solution Set, 10 drops/mL, 104'', 0.22 Micron Downstream High Pressure Extended Life Filter, 3 Injection Sites, Male Luer Lock Adapter, catalog 2C6593; Baxter Healthcare Corporation, Deer Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.