510(k) K172557 ยท DTK Filter, Intravascular, Cardiovascular
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
| Applicant | William Cook Europe Aps, Bjaeverskov, DK |
| Decision | Substantially Equivalent, Nov 20, 2017 |
| Received | Aug 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP
Product Usage:
The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmon Terminated |
DTK | None listed |
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP
Product Usage:
The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmona Terminated |
DTK | None listed |
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP
Product Usage:
The Gunther Tulip Filter is intended for the prevention of recurrent pul Terminated |
DTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.