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angiojet solent omni thrombectomy set
Medrad
Summary: The AngioJet Solent Omni Thrombectomy Set is a medical device used for mechanical thrombectomy in venous systems. It is primarily used by interventional radiologists and vascular surgeons to remove thrombus from blood vessels.
FDA Clearance Information
Pathway
510K
Number
K111182 ↗
Decision Date
May 24, 2011
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Solent Omni Thrombectomy Set was cleared through the FDA 510(k) pathway on May 24, 2011. Manufactured by Medrad, it is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Solent Omni Thrombectomy Set is a catheter-based device designed to remove thrombus (blood clots) from the venous system. It operates by using high-velocity saline jets to create a vacuum effect that breaks up and removes thrombus. This device is part of a mechanical thrombectomy system that allows for minimally invasive intervention, reducing the need for open surgery.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is utilized in procedures to treat deep vein thrombosis (DVT) and other venous thromboembolic conditions. The device is suitable for use in hospitals and specialized clinics where endovascular procedures are performed, and it is often used in patients who are at risk of complications from untreated thrombus.
Indications for Use
The AngioJet Solent Omni is indicated for patients with thrombus in the venous system. It is particularly useful for those with deep vein thrombosis or other conditions where blood clots obstruct normal blood flow.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters. It is compatible with standard endovascular equipment and requires careful technique to ensure effective thrombus removal. Clinicians should be trained in its use to optimize outcomes and minimize risks.
Frequently Asked Questions
What is the AngioJet Solent Omni Thrombectomy Set used for?
It is used for the removal of thrombus 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 endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in the venous system, particularly for conditions like 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.