510(k) K171712 ยท DTK Filter, Intravascular, Cardiovascular
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter 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, Aug 7, 2017 |
| Received | Jun 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171712
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the prevention of Terminated |
DTK | None listed |
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the prevention of Terminated |
DTK | None listed |
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the Terminated |
DTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.