FDA Product Code HCG: Device, Neurovascular Embolization
Under FDA product code HCG, neurovascular embolization devices are cleared for the endovascular treatment of intracranial aneurysms and other neurovascular lesions.
These devices — including detachable coils, flow diverters, and intrasaccular implants — are delivered through microcatheters navigated into the cerebral vasculature to occlude aneurysm sacs or redirect blood flow away from the weakened vessel wall, preventing rupture.
HCG devices are Class II medical devices, regulated under 21 CFR 882.5950 and reviewed by the FDA Neurology panel.
Leading manufacturers include Stryker Neurovascular, Medos International SARL and Penumbra, Inc..
List of Device, Neurovascular Embolization devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Device, Neurovascular Embolization devices (product code HCG). 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 →