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
- K211875 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 Cook Celect Platinum Vena Cava Filter Set is an intravascular filter designed for the prevention of pulmonary embolism. According to the FDA classification, it falls under the category of Filter, Intravascular, Cardiovascular. This device is intended for placement within the vena cava to capture thromboembolic material, reducing the risk of recurrent pulmonary embolism in patients where anticoagulant therapy is contraindicated or ineffective.
The filter set is available in configurations for femoral vein, jugular vein, or combined femoral and jugular vein approaches. Supplied sterile and intended for single-use, it is regulated under FDA 510(k) clearance (K211875) as substantially equivalent to prior devices. The device adheres to regulatory standards outlined in 21 CFR 870.3375 and is distributed exclusively through licensed medical practitioners. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What is the Cook Celect Platinum Vena Cava Filter Set used for?
This device is designed to prevent pulmonary embolism by capturing thromboembolic material within the vena cava. It is specifically intended for patients where anticoagulant therapy is either contraindicated or ineffective, helping to reduce the risk of recurrent pulmonary embolism.
What are the available configurations for placement of the Cook Celect Platinum Vena Cava Filter Set?
The filter set is available in three configurations: for femoral vein approach, jugular vein approach, or a combined femoral and jugular vein approach. These options accommodate different clinical scenarios and patient needs.
Is the Cook Celect Platinum Vena Cava Filter Set sterile and single-use?
Yes, the filter set is supplied sterile and is intended for single-use only. This ensures patient safety and compliance with sterile medical device protocols, reducing the risk of infection or contamination.
How is the Cook Celect Platinum Vena Cava Filter Set regulated?
The device is regulated under FDA 510(k) clearance (K211875) and is classified as substantially equivalent to prior devices. It adheres to regulatory standards outlined in 21 CFR 870.3375, ensuring its safety and effectiveness for the intended use.
Who can distribute and use the Cook Celect Platinum Vena Cava Filter Set?
The device is distributed exclusively through licensed medical practitioners. This ensures proper clinical oversight and adherence to regulatory requirements for intravascular filters.
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, PDF Cook Celect® Platinum Vena Cava Filter Set for Femoral and Jugular Vein ..., Celect™ Platinum Vena Cava Filter - Cook Medical, PDF EN Cook Celect® PlatinumVena Cava Filter Set for Femoral Vein Approach ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211875 | Class II | Active |
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Manufacturer
- Manufacturer
- William Cook Europe ApS
Sources (1)
- FDA 510(k) K211875 24 fields · synced Oct 5, 2026