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cunther tulip r vena cava filter set for femoral approach cook celect r vena cava filter for femoral approach

William Cook Europe Aps

Summary: The Cunther Tulip R and Cook Celect R are vena cava filters used to prevent pulmonary embolism in patients with contraindications to anticoagulation. These devices are typically used by interventional radiologists or vascular surgeons.

FDA Clearance Information

Pathway 510K
Number K112119 ↗
Decision Date March 30, 2012
Product Code DTK
Device Class Class 2
Evidence 11 studies

The Cunther Tulip R and Cook Celect R vena cava filters were cleared via the FDA 510(k) pathway on March 30, 2012, by William Cook Europe Aps. They are classified as Class 2 medical devices.

What It Is

The Cunther Tulip R and Cook Celect R are inferior vena cava (IVC) filters designed to capture and prevent blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism. These filters are inserted into the inferior vena cava via a femoral approach and are typically used in patients who cannot tolerate anticoagulation therapy. The devices are made of durable materials and are designed to be either permanent or retrievable, depending on the patient's needs.

Clinical Applications

These IVC filters are commonly used in patients at high risk for venous thromboembolism, such as those with deep vein thrombosis (DVT) who cannot receive anticoagulants. They are often placed in hospital settings by interventional radiologists or vascular surgeons. The filters are particularly useful in trauma patients, post-surgical patients, or those with a history of recurrent embolism despite anticoagulation.

Indications for Use

The FDA indications for these filters include preventing pulmonary embolism in patients who have contraindications to anticoagulation therapy. They are also indicated for patients who have experienced recurrent embolism while on anticoagulation.

Practical Considerations

These filters are available in various sizes to accommodate different patient anatomies and are compatible with standard femoral access techniques. Clinicians should be familiar with imaging guidance for precise placement and consider the retrievability of the filter based on patient prognosis and treatment goals.

Linked Studies (11)

PubMed • 2025

Two-Year Outcomes from the Cook Inferior Vena Cava Filter (CIVC) Study.

Journal of vascular and interventional radiology : JVIR

Prospective View Source →
PubMed • 2023

Management of failed inferior vena cava filter retrieval for complex cases: A case series.

Journal of clinical imaging science

View Source →
PubMed • 2022

Filter tilting and retrievability of the Celect and Denali inferior vena cava filters using propensity score-matching analysis.

European journal of radiology open

RCT|prospective|retrospective|case Series|other View Source →
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 • 2018

Complications and retrieval characteristics of Celect Platinum inferior vena cava filters.

Journal of vascular surgery. Venous and lymphatic disorders

Retrospective 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 • 2009

Initial experience in 115 patients with the retrievable Cook Celect vena cava filter.

Journal of medical imaging and radiation oncology

Retrospective View Source →
PubMed • 2009

Deployment performance and retrievability of the Cook Celect vena cava filter.

Journal of vascular and interventional radiology : JVIR

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

Celect Vena Cava Filter Clinical Trial

View Source →
ClinicalTrials.gov

Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study

View Source →

Frequently Asked Questions

What is Cunther Tulip R & Cook Celect R used for?

These devices are 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 these devices.

What are the FDA-cleared indications?

The devices are indicated for preventing pulmonary embolism in patients with contraindications to anticoagulation or those with recurrent embolism despite anticoagulation.

Related Device Categories

IVC Filters
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.

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