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angiojet ultra power pulse kit
Medrad
Summary: The AngioJet Ultra Power Pulse Kit is a mechanical thrombectomy device used for removing thrombus in venous systems. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K130381 ↗
Decision Date
July 29, 2013
Product Code
QEW
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra Power Pulse Kit was cleared through the FDA 510(k) pathway on July 29, 2013. Manufactured by Medrad, it is classified as a Class 2 device under product code QEW.
What It Is
The AngioJet Ultra Power Pulse Kit is a medical device designed for mechanical thrombectomy, specifically targeting thrombus removal in venous systems. It operates by using high-velocity saline jets to fragment and remove thrombus, providing an effective means of restoring blood flow. The device is part of the AngioJet system, which is known for its efficacy in treating large clot burdens.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings to treat patients with deep vein thrombosis (DVT) or other venous thromboembolic conditions. It is particularly useful in cases where pharmacological thrombolysis is contraindicated or insufficient. The AngioJet Ultra Power Pulse Kit is often employed in hospital settings, especially in catheterization labs, to manage acute thrombotic events.
Indications for Use
The FDA has cleared the AngioJet Ultra Power Pulse Kit for use in patients with thrombotic occlusions in the venous system. This includes conditions like deep vein thrombosis, where blood clots obstruct blood flow in major veins.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of patient anatomies. Clinicians should be familiar with the technique of catheter-based thrombectomy and consider patient-specific factors such as clot size and location when selecting this device.
Frequently Asked Questions
What is the AngioJet Ultra Power Pulse Kit used for?
It is used for mechanical thrombectomy to remove thrombus from the venous system, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons primarily use this device.
What are the FDA-cleared indications?
The device is indicated for the 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.