đź“‹ FDA Reference
cook clect vena cava filter gunther tulip vena cava filter retrieval set
William Cook Europe Aps
Summary: The Cook Clect Vena Cava Filter is a medical device used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K073374 ↗
Decision Date March 7, 2008
Product Code DTK
Device Class Class 2
Evidence 10 studies
The Cook Clect Vena Cava Filter was cleared through the FDA 510(k) pathway on March 7, 2008. Manufactured by William Cook Europe Aps, it is classified as a Class 2 device under product code DTK.
What It Is
The Cook Clect Vena Cava Filter is a retrievable filter designed for placement in the inferior vena cava (IVC) to capture emboli and prevent them from reaching the pulmonary arteries. It consists of a metal framework that expands to fit the IVC, allowing blood flow while trapping clots. The filter can be retrieved when it is no longer needed, providing flexibility in patient management.
Clinical Applications
This device is commonly used in patients at risk of venous thromboembolism (VTE) who cannot be managed with anticoagulation therapy alone. It is often employed in trauma patients, those undergoing major surgery, or individuals with a history of deep vein thrombosis (DVT). Interventional radiologists and vascular surgeons typically perform the placement and retrieval procedures in hospital settings.
Indications for Use
The FDA-cleared indications for the Cook Clect Vena Cava Filter include prevention of recurrent pulmonary embolism in patients with contraindications to anticoagulation therapy, or in those who have experienced recurrent embolism despite adequate anticoagulation.
Practical Considerations
The filter is available in various sizes to accommodate different IVC diameters, and it is compatible with standard delivery systems. Proper imaging and technique are crucial for successful placement and retrieval, and clinicians should be familiar with the anatomy of the IVC and surrounding structures.
Linked Studies (10)
PubMed • 2022
Case report: Endoluminal removal of a retrievable conical inferior vena cava filter with a ruptured retraction hook attached to the wall.
Frontiers in surgery
Case Report View Source → PubMed • 2016
Factors affecting Cook Gunther Tulip and Cook Celect inferior vena cava filter retrieval success.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2014
Safety and efficacy of the Gunther Tulip retrievable vena cava filter: midterm outcomes.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2013
Successful removal of a Gunther tulip vena cava filter with wall-embedded hook and migration during a retrieval attempt.
Acta radiologica short reports
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2013
Retrieval of gunther tulip vena cava filter with thrombosed hook and a leg incorporated into the vena cava wall.
Annals of vascular diseases
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2011
Endovascular repair of a perforation of the vena caval wall caused by the retrieval of a Gunther Tulip filter after long-term implantation.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2008
Form and function of vena cava filters: how do optional filters measure up?
Vascular
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2007
Evaluation of retrievability of the Gunther tulip vena cava filter.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2005
New optional IVC filter for percutaneous retrieval--in vitro evaluation of embolus capturing efficiency.
RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin
RCT|prospective|retrospective|case Series|other View Source → ClinicalTrials.gov
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
View Source →Frequently Asked Questions
What is the Cook Clect Vena Cava Filter used for?
It is used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for preventing recurrent pulmonary embolism in patients who cannot use anticoagulation therapy or have recurrent embolism despite it.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.