510(k) K964918 ยท FPA Set, Administration, Intravascular
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
| Applicant | Critical Device Corp., Brea CA, US |
| Decision | Substantially Equivalent, Apr 14, 1997 |
| Received | Dec 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964918
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP I.V. Catheter Extension Set, 8.2" (20.9 cm), 0.3 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter; an Rx sterile device; Baxter Healthcare Corpo Terminated |
FPA | None listed |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP I.V. Catheter Extension Set, 6.0" (15.2 cm), 0.5 mL, PosiFlow Positive Displacement Access Device 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 Non-DEHP Y-Type Catheter Extension Set, 6.6" (16.8 cm)., 1.1 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile devi Terminated |
FPA | None listed |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx ste Terminated |
FPA | None listed |
| Jun 1, 2005 | Baxter Healthcare Corp. Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile device with PosiFlow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., 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 |
| Apr 8, 2005 | Baxter Healthcare Corp. Baxter Posiflow Access Device for IV Access; product code 2N9050; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.