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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 ?
510(k)
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.
FDA-Cleared Indications
- Removal of thrombi from peripheral arteries.
Clinical Applications
- Catheter-based removal of blood clots from peripheral arteries.
- Treatment of arterial occlusions caused by thrombus when mechanical thrombectomy is selected.
- Use during endovascular treatment of peripheral arterial thrombotic obstruction.
Practical Considerations
- The system is used with standard catheterization techniques under fluoroscopic imaging, typically through arterial access such as the common femoral artery.
- Available catheter sizes and device configurations should be matched to the target vessel diameter and clot burden according to the current instructions for use.
- Operators should be trained in guidewire and catheter manipulation, aspiration technique, and management of potential embolization or vessel injury.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; the device should not be assumed to be MRI safe while in place.
- Contraindications, warnings, anticoagulation requirements, and access-site considerations should be reviewed in the current FDA-cleared labeling before use.
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.