Injector and Syringe, Angiographic

How Is DXT Classified?

Injector And Syringe, Angiographic is FDA product code DXT, Class 2, 21 CFR 870.1650.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 17 clearances under this code; the FDA took a median of 210 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 70 recalls under this product code since 2003. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Packaging process control (15), Nonconforming Material/Component (10) and Device Design (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.