510(k) K013621 ยท FPA Set, Administration, Intravascular
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc., Sandy UT, US |
| Decision | Substantially Equivalent, Apr 16, 2002 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2015 | Becton Dickinson & Company BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc.
An accessory to an intravascular administration set th Terminated |
FPA | None listed |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B. Terminated |
FPA | None listed |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498. Terminated |
FPA | None listed |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977. Terminated |
FPA | None listed |
| Feb 2, 2010 | Becton Dickinson Medical Systems BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc. Terminated |
FPA | None listed |
| Feb 2, 2010 | Becton Dickinson Medical Systems BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc. Terminated |
FPA | None listed |
| Feb 2, 2010 | Becton Dickinson Medical Systems BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc. Terminated |
FPA | None listed |
| Feb 2, 2010 | Becton Dickinson Medical Systems BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc. Terminated |
FPA | None listed |
| Feb 2, 2010 | Becton Dickinson Medical Systems MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150, Terminated |
FPA | None listed |
| Feb 2, 2010 | Becton Dickinson Medical Systems MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151 Terminated |
FPA | None listed |
| Feb 2, 2010 | Becton Dickinson Medical Systems MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.