510(k) K211874 · DTK Filter, Intravascular, Cardiovascular
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
| Applicant | William Cook Europe Aps, Bjaeverskov, DK |
| Decision | Substantially Equivalent, Jul 28, 2021 |
| Received | Jun 17, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211874
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2022 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
Catalog Number/GPN:
IGTCFS-65-1-FEM-TULIP G52917;
IGTCFS-65-1-JUG-TULIP G52916;
IGTCFS-65-1-UNI-TULIP G52918 Terminated |
DTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.