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angiojet ultra dvx thrombectomy set
Medrad
Summary: The AngioJet Ultra DVX Thrombectomy Set is a mechanical device used for the removal of thrombi in venous systems. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K113428 ↗
Decision Date
December 2, 2011
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra DVX Thrombectomy Set was cleared through the FDA 510(k) pathway on December 2, 2011. Manufactured by Medrad, it is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Ultra DVX Thrombectomy Set is a mechanical thrombectomy device designed to remove blood clots from the venous system. It operates by using high-velocity saline jets to create a vacuum effect, which fragments and removes thrombi. This device is particularly useful in cases where pharmacological thrombolysis is contraindicated or ineffective.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for the treatment of deep vein thrombosis (DVT) and other venous thromboembolic conditions. It is suitable for use in hospitals and specialized clinics, particularly for patients who require rapid clot removal to prevent complications such as post-thrombotic syndrome.
Indications for Use
The AngioJet Ultra DVX is indicated for patients with venous thromboembolic conditions, such as deep vein thrombosis, where mechanical removal of the clot is necessary. It is particularly useful in patients who are not candidates for or have not responded to pharmacological treatments.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and is compatible with standard vascular access sheaths. Proper technique involves careful navigation through the venous system to ensure effective clot removal while minimizing vessel trauma.
Frequently Asked Questions
What is AngioJet Ultra DVX Thrombectomy Set used for?
It is used for the mechanical removal of thrombi from the venous system, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital and specialized clinic settings.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi in venous thromboembolic conditions, such as deep vein thrombosis.
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.