đź“‹ FDA Reference
angiojet ultra spiroflex vg thrombectomy set model 106608
Possis Medical
Summary: The AngioJet Ultra Spiroflex VG 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 in patients with venous thrombosis.
FDA Clearance Information
Pathway
510K
Number
K080806 ↗
Decision Date
April 4, 2008
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra Spiroflex VG Thrombectomy Set, manufactured by Possis Medical, was cleared by the FDA via the 510(k) pathway on April 4, 2008. It is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Ultra Spiroflex VG is a thrombectomy device designed to remove thrombus from the venous system using a high-pressure saline jet to break up and remove clots. It operates by creating a vacuum effect that draws the thrombus into the catheter where it is fragmented and aspirated. This device is particularly useful in treating patients with deep vein thrombosis (DVT) and other venous thromboembolic conditions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat venous thrombosis, particularly in the deep veins of the legs. The device is suitable for use in hospitals and specialized vascular centers, and it is typically used in adult patients who present with significant thrombotic burden that requires mechanical intervention.
Indications for Use
The FDA-cleared indications for the AngioJet Ultra Spiroflex VG include the mechanical removal of thrombus from the venous system. It is intended for patients with conditions such as deep vein thrombosis where traditional anticoagulation therapy alone is insufficient.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and is compatible with standard interventional radiology equipment. Clinicians should be familiar with the technique of mechanical thrombectomy and consider patient-specific factors such as clot burden and vessel anatomy when selecting this device.
Frequently Asked Questions
What is the AngioJet Ultra Spiroflex VG 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 in hospital and specialized vascular settings.
What are the FDA-cleared indications?
The device is indicated for the mechanical thrombectomy 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.