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Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

FDA product code POL · 17 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.5600
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-11-10 – 2025-02-28

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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