đź“‹ FDA Reference
angiojet ultra xmi 105041 xvg 105042 and spiroflex 106553 thrombectomy sets
Possis Medical
Summary: The AngioJet Ultra Thrombectomy Sets are mechanical devices used for removing thrombi from veins. They are typically used by interventional radiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K072769 ↗
Decision Date
November 14, 2007
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra Thrombectomy Sets, manufactured by Possis Medical, were cleared through the FDA 510(k) pathway on November 14, 2007. They are classified as Class 2 medical devices.
What It Is
The AngioJet Ultra Thrombectomy Sets are mechanical devices designed for the removal of thrombi, or blood clots, from venous systems. Utilizing high-speed saline jets, these devices create a vacuum effect to break up and remove clots. This technology is particularly useful in restoring blood flow in patients with deep vein thrombosis or other venous occlusions.
Clinical Applications
These thrombectomy sets are commonly used in interventional radiology and vascular surgery to treat patients with acute deep vein thrombosis or other venous thromboembolic events. They are typically employed in hospital settings, particularly in catheterization labs, where rapid restoration of blood flow is critical. The devices are suitable for adult patients who present with symptomatic venous occlusions.
Indications for Use
The FDA-cleared indications for these devices include the removal of thrombi from veins, particularly in cases of deep vein thrombosis. They are intended for use in patients who require mechanical thrombectomy to restore venous blood flow.
Practical Considerations
The AngioJet Ultra Thrombectomy Sets come in various sizes to accommodate different vessel diameters. They are compatible with standard catheterization equipment and require careful handling to ensure effective clot removal. Proper technique is essential to minimize potential complications such as vessel injury.
Frequently Asked Questions
What is the AngioJet Ultra used for?
The AngioJet Ultra is used for mechanically removing blood clots from veins, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is cleared for the removal of thrombi from veins, especially 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.