Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celec…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171712 FDA 510(k)
- FDA Product Code
- DTK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3375 FDA 510(k)
- Regulation Number
- 870.3375 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a filter, intravascular, cardiovascular, as defined in the nomenclature authority. It is a vena cava filter set designed for placement via femoral or jugular vein approaches.
It is supplied as a set for femoral vein approach, jugular vein approach, or both femoral and jugular vein approaches. The device received FDA 510(k) clearance under K171712 with a traditional clearance type and is classified as a Class II device under regulation number 870.3375. It is manufactured by William Cook Europe ApS in Bjaeverskov, Denmark.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Celect Platinum® Vena Cava Filter - Cook Medical, Celect™ Platinum Vena Cava Filter - Cook Medical, PDF Cook Celect® Platinum Vena Cava Filter Set for Femoral and Jugular Vein ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171712 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- William Cook Europe ApS
Sources (1)
- FDA 510(k) K171712 24 fields · synced Oct 6, 2026