đź“‹ FDA Reference
angiojet ultra xpeedior thrombectomy set model 105040 105042 106552 105043 105041 106553 105039
Possis Medical
Summary: The AngioJet Ultra Xpeedior Thrombectomy Set is a mechanical thrombectomy device used to remove thrombus from venous systems. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K071342 ↗
Decision Date
July 31, 2007
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra Xpeedior Thrombectomy Set, manufactured by Possis Medical, was cleared via the FDA 510(k) pathway on July 31, 2007. It is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Ultra Xpeedior Thrombectomy Set is a catheter-based system designed for the removal of thrombus from venous systems. It operates by using high-velocity saline jets to create a vacuum effect that breaks up and removes blood clots. This device is particularly useful in restoring blood flow in patients with deep vein thrombosis or other thrombotic conditions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings to treat patients with venous thromboembolism, including deep vein thrombosis. It is suitable for use in hospitals and specialized clinics where mechanical thrombectomy procedures are performed. The device is often used in patients who are not candidates for anticoagulation therapy or when rapid clot removal is necessary.
Indications for Use
The FDA indications for this device include the mechanical removal of thrombus in the venous system. It is intended for patients with conditions such as deep vein thrombosis where clot removal is required to restore venous circulation.
Practical Considerations
The AngioJet Ultra Xpeedior Thrombectomy Set is available in various sizes to accommodate different vessel diameters. It is compatible with standard angiographic equipment and requires careful technique to ensure effective thrombus removal while minimizing vessel trauma.
Frequently Asked Questions
What is AngioJet Ultra Xpeedior Thrombectomy Set used for?
It is used for the mechanical 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.
What are the FDA-cleared indications?
The device is indicated for the mechanical removal of thrombus in the venous system, 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.