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 Stryker Neurovascular and Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.
List of Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment devices (product code POL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Neurology FDA review panel. Browse all Neurology devices →