510(k) K211875 ยท DTK Filter, Intravascular, Cardiovascular
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum 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 K211875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2022 | Cook Medical Incorporated Cook Celect PlatinumVena Cava Filter Set
Catalog Number/GPN:
IGTCFS-65-1-FEM-CELECT-PT G34502;
IGTCFS-65-1-JUG-CELECT-PT G34309;
IGTCFS-65-1-UNI-CELECT-PT G34505; Terminated |
DTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.