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angiojet solent proxi thrombectomy set model 109676-001
Medrad Interventional/Possis
Summary: The AngioJet Solent Proxi 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 from blood vessels.
FDA Clearance Information
Pathway
510K
Number
K101406 ↗
Decision Date
June 16, 2010
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Solent Proxi Thrombectomy Set, manufactured by Medrad Interventional/Possis, was cleared via the FDA 510k pathway on June 16, 2010. It is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Solent Proxi Thrombectomy Set is a mechanical thrombectomy device designed to remove thrombus (blood clots) from the venous system. It operates by using high-velocity saline jets to break up and remove thrombus from blood vessels. This device is particularly useful in restoring blood flow in patients with deep vein thrombosis (DVT) or other venous occlusions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat patients with conditions such as deep vein thrombosis (DVT) or pulmonary embolism (PE). The AngioJet system is particularly beneficial in acute settings where rapid restoration of blood flow is critical, and it is often used in hospital catheterization labs or specialized vascular centers.
Indications for Use
The FDA has cleared this device for use in removing thrombus from the venous system. It is indicated for patients with conditions like deep vein thrombosis, where blood clots obstruct normal blood flow and require mechanical intervention to restore circulation.
Practical Considerations
The AngioJet Solent Proxi Thrombectomy Set is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheterization equipment and requires careful handling to ensure effective thrombus removal without damaging the vessel walls. Clinicians should be trained in its use to optimize outcomes and minimize complications.
Frequently Asked Questions
What is the AngioJet Solent Proxi Thrombectomy Set used for?
It is used for mechanically removing thrombus from the venous system, particularly in cases of deep vein thrombosis or pulmonary embolism.
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 cleared for removing thrombus from the venous system, particularly 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.