đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Removal of thrombus from peripheral arteries.
- Treatment of peripheral arterial thrombotic occlusions.
Clinical Applications
- Catheter-based removal of thrombus from peripheral arterial vessels.
- Treatment of peripheral arterial occlusions caused by blood clots.
- Use during peripheral endovascular thrombectomy procedures in a hospital catheterization laboratory or operating room.
Practical Considerations
- The system is available in different device sizes for use in appropriately sized peripheral vessels; operators should select the size according to vessel anatomy and the manufacturer’s instructions.
- It is used with catheter-based peripheral intervention equipment, including compatible guidewires and access systems.
- The procedure requires fluoroscopic or other appropriate imaging guidance and clinicians trained in peripheral endovascular techniques.
- The FDA record provided does not establish MRI safety; MRI compatibility should be confirmed in the current manufacturer’s labeling before scanning a patient with any retained component.
- Patient-specific factors, including vessel size, access-site condition, clot location and extent, bleeding risk, and the presence of fixed arterial disease, should be evaluated before treatment.
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.