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cook celect and gunther tulip vena cava filter sets

William Cook Europe Aps

Summary: The Cook Celect and Gunther Tulip Vena Cava Filter Sets are used for preventing pulmonary embolism in patients with contraindications to anticoagulation. Key evidence highlights their safety and effectiveness over long-term use.

FDA Clearance Information

Pathway 510K
Number K121057 ↗
Decision Date May 4, 2012
Product Code DTK
Device Class Class 2
Evidence 11 studies

The Cook Celect and Gunther Tulip Vena Cava Filter Sets received FDA clearance through the 510(k) pathway on May 4, 2012. Manufactured by William Cook Europe Aps, these devices are classified as Class 2 medical devices.

What It Is

The Cook Celect and Gunther Tulip Vena Cava Filter Sets are medical devices designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. They are intended for use in patients with contraindications to anticoagulation therapy.

Clinical Applications

These filters are commonly used in clinical scenarios where patients are at risk of venous thromboembolism but cannot undergo anticoagulation therapy. They are often employed in cases of recurrent deep vein thrombosis or pulmonary embolism.

Evidence Summary

The available literature includes 11 studies, comprising prospective, retrospective, and case reports, conducted between 2020 and 2025. These studies evaluate the safety, effectiveness, and retrieval practices of the filters.

Reported Outcomes

Published studies report successful retrieval of the filters and maintenance of inferior vena cava patency. The Cook Inferior Vena Cava Filter (CIVC) Study highlighted the device's safety and effectiveness over a two-year period.

Safety Profile

Reported complications include minor events such as broken pedicles retained in the inferior vena cava. The studies emphasize the importance of timely retrieval to minimize complications.

Evidence Limitations

The evidence is limited by the lack of randomized controlled trials and the potential for selection bias in non-randomized studies. Further research is needed to evaluate long-term outcomes and optimize retrieval practices.

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 are the clinical indications for Cook Celect and Gunther Tulip Vena Cava Filter Sets?

These filters are indicated for patients at risk of pulmonary embolism who have contraindications to anticoagulation therapy.

What outcomes have been reported in clinical studies?

Clinical studies have reported successful retrieval and maintenance of inferior vena cava patency, with a focus on safety and effectiveness.

What complications have been reported?

Reported complications include minor events such as broken pedicles retained in the inferior vena cava, emphasizing the need for timely retrieval.

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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