510(k) K130366 ยท DTK Filter, Intravascular, Cardiovascular
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
| Applicant | C.R. Bard, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, May 15, 2013 |
| Received | Feb 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2016 | Bard Peripheral Vascular Inc Denali Filter-Jugular/Subclavian Delivery System
Product Code: DL900J/DL950J;
Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. Terminated |
DTK | None listed |
| Feb 9, 2016 | Bard Peripheral Vascular Inc Denali Filter-Femoral Delivery System
Product Code: DL900F/DL950F;
Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. Terminated |
DTK | None listed |
| Feb 1, 2016 | Bard Peripheral Vascular Inc Denali Filter-Jugular/Subclavian DL950J
Denali Filter-Femoral Delivery DL950F.
Intravascular filters. Terminated |
DTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.