510(k) K915390 ยท FPA Set, Administration, Intravascular
3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Mar 12, 1992 |
| Received | Nov 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915390
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 3-Lead Extension Set, product code 1C8442; An Rx sterile, nonpyrogenic fluid pathway, 6'', 1.6 mL Vol., with 2 Interlink Injection Sites and a Male Luer Lock adapter; Baxter He 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.