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gunther tulip r vena cava filter retrieval set
Cook
Summary: The Gunther Tulip R Vena Cava Filter Retrieval Set is used to retrieve IVC filters. It's typically utilized by interventional radiologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K181757 ↗
Decision Date November 6, 2018
Product Code MMX
Device Class Class 2
Evidence 10 studies
The Gunther Tulip R Vena Cava Filter Retrieval Set was cleared through the FDA 510k pathway on November 6, 2018. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The Gunther Tulip R Vena Cava Filter Retrieval Set is a medical device designed for the retrieval of inferior vena cava (IVC) filters. These filters are used to prevent pulmonary embolism by capturing blood clots. The retrieval set allows for the safe and effective removal of these filters once they are no longer needed, minimizing potential complications associated with long-term filter placement.
Clinical Applications
This device is primarily used in interventional radiology procedures to retrieve IVC filters. It is commonly employed in hospital settings where patients have previously had an IVC filter placed to prevent pulmonary embolism. The retrieval procedure is typically performed on patients who no longer require the filter, such as those who have resolved their risk of thromboembolism or are transitioning to other anticoagulation therapies.
Indications for Use
The FDA indications for this device include the retrieval of IVC filters. It is intended for patients who have had an IVC filter placed and now require its removal, often due to a change in their clinical condition or treatment plan.
Practical Considerations
The Gunther Tulip R Retrieval Set is compatible with specific IVC filters, so it's important to verify compatibility before use. The procedure requires fluoroscopic guidance to ensure accurate retrieval. Clinicians should be familiar with the retrieval technique to minimize complications.
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 Gunther Tulip R Vena Cava Filter Retrieval Set used for?
It is used for the retrieval of inferior vena cava (IVC) filters that are no longer needed by the patient.
What specialties typically use this device?
Interventional radiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the retrieval of IVC filters in patients who no longer require them.
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.