POL

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Product code

POL

Device name

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Device class

Class 2

21 CFR

21 CFR 882.5600

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

18 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-02-28.

1 summaries are archived here for direct download.