Device, Neurovascular Embolization

How Is HCG Classified?

Device, Neurovascular Embolization is FDA product code HCG, Class 2, 21 CFR 882.5950.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 4 clearances under this code; the FDA took a median of 108 days from receipt to decision on them. 3 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 68 recalls under this product code since 2007. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process change control (29), Process design (16) and Process control (6). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.