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angiojet ultra dvx thrombectomy set model 106552
Possis Medical
Summary: The AngioJet Ultra DVX 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 blood clots from veins.
FDA Clearance Information
Pathway
510K
Number
K072269 ↗
Decision Date
September 8, 2007
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra DVX Thrombectomy Set by Possis Medical was cleared through the FDA 510(k) pathway on September 8, 2007. It is 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 thrombus (blood clots) from the venous system. It operates by using high-speed saline jets to create a vacuum effect, effectively breaking up and aspirating the clot. This device is particularly useful in cases where anticoagulation therapy alone is insufficient or contraindicated.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings to treat conditions such as deep vein thrombosis (DVT) and other venous thromboembolic disorders. It is particularly beneficial in acute settings where rapid clot removal is necessary to restore venous flow and prevent complications. Patients who have contraindications to thrombolytic therapy or require rapid symptom relief are typical candidates.
Indications for Use
The FDA indications for the AngioJet Ultra DVX Thrombectomy Set include the removal of thrombus from the venous system. It is indicated for patients with conditions like deep vein thrombosis, where mechanical removal of the clot is necessary.
Practical Considerations
The AngioJet system is available in various sizes to accommodate different vessel diameters and is compatible with standard catheterization techniques. Clinicians should be trained in its use to optimize outcomes and minimize potential complications, such as vessel injury.
Frequently Asked Questions
What is the AngioJet Ultra DVX Thrombectomy Set used for?
It is used for the mechanical removal of blood clots from the venous system, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombus from the venous system, such as in cases of 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.