FDA Product Code POL: Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Mechanical thrombectomy for acute ischemic stroke has transformed neurological outcomes. FDA product code POL covers neurovascular mechanical thrombectomy devices for acute ischemic stroke treatment.

These stent retrievers and aspiration systems are deployed into occluded intracranial arteries to capture and remove the obstructing clot, restoring cerebral blood flow within the critical treatment window. They have become the standard of care for large vessel occlusion stroke.

POL devices are Class II medical devices, regulated under 21 CFR 882.5600 and reviewed by the FDA Neurology panel.

Leading manufacturers include Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Stryker and Stryker Neurovascular.