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jeti aio peripheral thrombectomy system
Walk Vascular
Summary: The Jeti AIO Peripheral Thrombectomy System is a medical device used to remove blood clots from peripheral arteries. It is primarily used by interventional radiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K213565 ↗
Decision Date
February 1, 2022
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The Jeti AIO Peripheral Thrombectomy System was cleared through the FDA 510(k) pathway on February 1, 2022. Manufactured by Walk Vascular, it is classified as a Class 2 device under product code QEZ.
What It Is
The Jeti AIO Peripheral Thrombectomy System is a mechanical thrombectomy device designed to remove thrombi from peripheral arteries. It utilizes a combination of aspiration and mechanical disruption to effectively clear blood clots. This system is particularly useful in restoring blood flow and preventing complications associated with arterial blockages.
Clinical Applications
This device is commonly used in procedures to treat acute limb ischemia and other conditions caused by arterial thrombosis. It is typically employed in interventional radiology suites and vascular surgery departments. The primary patient population includes those with peripheral arterial disease or acute arterial occlusions.
Indications for Use
The FDA indications for the Jeti AIO Peripheral Thrombectomy System include the removal of thrombi from peripheral arteries. It is intended for patients experiencing conditions such as acute limb ischemia due to arterial blockages.
Practical Considerations
The Jeti AIO system is compatible with standard catheterization techniques and is available in various sizes to accommodate different vessel diameters. Clinicians should be familiar with catheter manipulation and aspiration techniques to optimize device performance.
Frequently Asked Questions
What is the Jeti AIO Peripheral Thrombectomy System used for?
It is used for the removal of blood clots from peripheral arteries to restore blood flow and prevent complications.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi from peripheral arteries, particularly in cases of acute limb ischemia.
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.