FDA product code POL

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Neurology·Class 2·21 CFR 882.5600
US regulatory classifications
US Product Code (FDA)
POL
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5600
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

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About this record

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.