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, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular and Phenox Limited.
FDA 510(k) Cleared Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Devices (Product Code POL)
About Product Code POL - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code POL since 2016, with 17 receiving FDA clearance (average review time: 144 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under POL have taken an average of 175 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.
POL devices are reviewed by the Neurology panel. Browse all Neurology devices →