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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 typically used by interventional radiologists and vascular surgeons to remove thrombus in patients with venous thrombosis.
FDA Clearance Information
Pathway
510K
Number
K082382 ↗
Decision Date
December 12, 2008
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra AVX Thrombectomy Set, manufactured by Possis Medical, was cleared via the FDA 510(k) pathway on December 12, 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 the venous system. It operates by using a high-speed saline jet to create a vacuum effect, which helps to break up and remove blood clots. This device is part of a broader category of interventional tools used to restore blood flow in patients with venous thrombosis.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in treating patients with deep vein thrombosis (DVT) or other forms of venous thromboembolism. The device is typically employed in hospital settings where specialized imaging and interventional capabilities are available, and it is used on patients who require rapid restoration of blood flow to prevent further complications.
Indications for Use
The FDA-cleared indications for the AngioJet Ultra AVX Thrombectomy Set include the mechanical removal of thrombus in venous systems. It is intended for patients with conditions such as deep vein thrombosis, where blood clots obstruct normal venous blood flow.
Practical Considerations
The AngioJet Ultra AVX Thrombectomy Set comes in various sizes to accommodate different vessel diameters. Clinicians should ensure compatibility with existing catheter systems and be familiar with the device's operation to optimize thrombus removal. Proper technique and imaging guidance are crucial for effective use.
Frequently Asked Questions
What is the AngioJet Ultra AVX Thrombectomy Set used for?
It is used for the mechanical removal of thrombus in venous systems, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the mechanical removal of thrombus in venous systems, 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.