510(k) K961495 ยท FPA Set, Administration, Intravascular
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Jun 26, 1996 |
| Received | Apr 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3703; An Rx sterile, nonpyrogenic fluid pathway with Needle Gauge 22, Needle Length 3/4'', Total Volume 0.40 mL, Total Length 9''; Ba Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3706; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 3/4'', Total Volume Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3707; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 3/4'', Total Volume Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3709; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 3/4'', Total Volume Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3710; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 1'', Total Volume 0. Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1'', Total Volume 0. Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3714; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 1'', Total Volume 0. Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3716; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 1-1/2'', Total Volum Terminated |
FPA | None listed |
| Jul 28, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured for Baxter Healthcare Corporation, Deerfie Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.