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angiojet ultra avx thrombectomy set model 105039
Possis Medical
Summary: The AngioJet Ultra AVX Thrombectomy Set is a medical device used for mechanical thrombectomy in venous systems. It is primarily utilized by interventional radiologists and vascular surgeons to remove thrombus in patients with venous thromboembolism.
FDA Clearance Information
Pathway
510K
Number
K073441 ↗
Decision Date
January 24, 2008
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra AVX Thrombectomy Set by Possis Medical was cleared through the FDA 510(k) pathway on January 24, 2008. It is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Ultra AVX Thrombectomy Set is a mechanical thrombectomy device designed to remove thrombus from venous systems. It operates by using high-velocity saline jets to create a vacuum effect, effectively breaking up and aspirating the clot. This device is part of the AngioJet system, which is known for its efficacy in treating thrombotic occlusions in various vascular territories.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly in the treatment of deep vein thrombosis (DVT) and other venous thromboembolic conditions. It is suitable for use in hospitals and specialized clinics, where procedures are performed on patients who require rapid and effective thrombus removal to restore venous circulation. The device is often used in patients who are not candidates for anticoagulation therapy alone.
Indications for Use
The FDA-cleared indications for this device include the removal of thrombus in the venous system. It is intended for patients with conditions like deep vein thrombosis, where mechanical removal of the clot is necessary to restore blood flow and prevent complications.
Practical Considerations
The AngioJet Ultra AVX Thrombectomy Set is compatible with various catheter sizes, allowing for flexibility in different anatomical settings. Clinicians should be familiar with the device's operation and ensure proper technique to maximize efficacy and minimize complications. It is important to consider patient-specific factors such as clot burden and location when selecting this device.
Frequently Asked Questions
What is the AngioJet Ultra AVX Thrombectomy Set used for?
It is used for the mechanical removal of thrombus in 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 thrombus in the venous system, such as in patients with 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.