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, Balt USA, LLC and MicroPort NeuroTech (Shanghai) Co., Ltd..