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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 thrombus (blood clots) from peripheral arteries. It is typically used by interventional radiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K201998 ↗
Decision Date
November 17, 2020
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 November 17, 2020. It is manufactured by Walk Vascular and 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 blood clots from peripheral arteries. It works by using a combination of aspiration and mechanical disruption to effectively clear thrombus. This system is particularly useful in restoring blood flow in patients with peripheral arterial occlusions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery to treat patients with peripheral artery disease (PAD) who have developed acute or chronic thrombotic occlusions. It is suitable for use in hospital settings, particularly in catheterization labs or operating rooms. The device is beneficial for patients who are at risk of limb ischemia due to clot formation.
Indications for Use
The Jeti AIO Peripheral Thrombectomy System is indicated for patients with peripheral arterial thrombotic occlusions. It is used to remove blood clots that can cause reduced blood flow and potential tissue damage.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in peripheral interventions. Clinicians should be familiar with catheter-based techniques and consider patient-specific anatomical factors when using the device.
Frequently Asked Questions
What is Jeti AIO Peripheral Thrombectomy System used for?
It is used to remove blood clots from peripheral arteries to restore blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombus in peripheral arterial occlusions.
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.