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angiojet solent dista thrombectomy set
Medrad
Summary: The AngioJet Solent Dista 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 (blood clots) from blood vessels.
FDA Clearance Information
Pathway
510K
Number
K113363 ↗
Decision Date
June 6, 2012
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Solent Dista Thrombectomy Set was cleared through the FDA 510k pathway on June 6, 2012. Manufactured by Medrad, it is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Solent Dista Thrombectomy Set is a catheter-based system designed for the removal of thrombus from blood vessels. It utilizes high-velocity saline jets to create a vacuum effect that breaks up and removes clots. This device is particularly useful in restoring blood flow in patients with venous thrombosis.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat deep vein thrombosis (DVT) and other venous thromboembolic conditions. Patients who are candidates for this device typically have acute or chronic thrombotic occlusions that require mechanical intervention.
Indications for Use
The FDA indications for the AngioJet Solent Dista Thrombectomy Set include the removal of thrombus in venous systems. It is intended for patients with conditions such as deep vein thrombosis where clot removal is necessary to restore proper blood flow.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful technique to ensure effective clot removal while minimizing vessel trauma. Clinicians should be trained in its use to optimize outcomes.
Frequently Asked Questions
What is the AngioJet Solent Dista Thrombectomy Set used for?
It is used for the mechanical removal of thrombus (blood clots) from venous systems, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital and surgical settings.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombus in venous systems to restore blood flow in 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.