đź“‹ FDA Reference
angiojet ultra dvx thrombectomy set model 106552-001 angiojet ultra xpeedior thrombectomy set model 105040-001
Possis Medical
Summary: The AngioJet Ultra DVX and Xpeedior are mechanical thrombectomy devices used to remove thrombi in venous systems. They are primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K090253 ↗
Decision Date
April 8, 2009
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra DVX and Xpeedior thrombectomy sets were cleared via the FDA 510(k) pathway on April 8, 2009. Manufactured by Possis Medical, these devices are classified as Class 2 under product code QEZ.
What It Is
The AngioJet Ultra DVX and Xpeedior are mechanical thrombectomy devices designed to remove blood clots from veins. They operate by using high-speed saline jets to create a vacuum effect, which breaks up and removes thrombi. These devices are part of a broader category of endovascular tools used to restore blood flow in patients with venous thromboembolism.
Clinical Applications
These devices are commonly used in interventional radiology and vascular surgery settings to treat patients with deep vein thrombosis (DVT) or other venous thromboembolic conditions. They are particularly useful in acute settings where rapid clot removal is necessary to prevent complications such as pulmonary embolism. The devices are suitable for use in hospitals with specialized endovascular suites.
Indications for Use
The FDA-cleared indications for these devices include the removal of thrombi from the venous system. They are intended for patients who have developed blood clots in veins, which can lead to serious conditions if not treated promptly.
Practical Considerations
The AngioJet systems are compatible with a range of catheter sizes, allowing for flexibility in different vascular anatomies. Clinicians should be familiar with the technique of using high-pressure saline jets and ensure proper setup of the device to maximize efficacy and minimize complications.
Frequently Asked Questions
What is AngioJet Ultra DVX & Xpeedior used for?
These devices are used for the mechanical removal of blood clots from the venous system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these devices.
What are the FDA-cleared indications?
The devices are indicated for the removal of thrombi from the venous system in patients with 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.