đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Removal of thrombus from peripheral arteries.
- Treatment of peripheral arterial occlusions when mechanical thrombectomy is indicated.
Clinical Applications
- Catheter-based removal of thrombus from peripheral arteries.
- Endovascular treatment of selected acute peripheral arterial occlusions.
- Restoration of blood flow in an occluded peripheral artery after evaluation by a vascular specialist.
- Use in an interventional radiology or vascular surgery procedure under fluoroscopic imaging.
Practical Considerations
- The system is intended for use by clinicians trained in endovascular and thrombectomy techniques.
- Device size and catheter compatibility must be matched to the target vessel and the manufacturer's instructions for use.
- The procedure generally requires vascular access, fluoroscopic imaging, and local anesthesia with or without moderate sedation; some cases may require general anesthesia.
- MRI safety depends on the specific device components and whether any components remain in the patient. The manufacturer's current labeling should be reviewed before MRI.
- Potential complications include bleeding or hematoma at the access site, arterial injury, embolization, vessel perforation, infection, contrast reaction, kidney injury, and incomplete clot removal.
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.