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jeti 88 peripheral thrombectomy system
Walk Vascular
Summary: The Jeti 88 Peripheral Thrombectomy System is a medical device used for removing blood clots from peripheral arteries. It is primarily used by interventional radiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K183403 ↗
Decision Date
April 17, 2019
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The Jeti 88 Peripheral Thrombectomy System was cleared through the FDA 510(k) pathway on April 17, 2019. It is manufactured by Walk Vascular and is classified as a Class 2 device under product code QEZ.
What It Is
The Jeti 88 Peripheral Thrombectomy System is a mechanical thrombectomy device designed to remove thrombi from peripheral arteries. It operates by using a combination of aspiration and mechanical disruption to effectively clear blood clots. This device is particularly useful in restoring blood flow in patients with acute limb ischemia or other peripheral arterial occlusions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is suitable for patients with acute or chronic peripheral arterial occlusions, often seen in conditions like peripheral artery disease. The Jeti 88 is typically employed in hospital catheterization labs or operating rooms, where rapid clot removal can significantly improve patient outcomes.
Indications for Use
The Jeti 88 is indicated for patients with blood clots in peripheral arteries, which can lead to reduced blood flow and potential tissue damage. It is used to treat conditions such as acute limb ischemia, where quick restoration of blood flow is critical.
Practical Considerations
The Jeti 88 system is compatible with standard catheterization lab equipment and requires familiarity with endovascular techniques. It is available in sizes that accommodate various vessel diameters, making it versatile for different patient anatomies.
Frequently Asked Questions
What is the Jeti 88 Peripheral Thrombectomy System used for?
It is used for the removal of 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 thrombi from peripheral arteries in patients with conditions like 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.