System, Balloon, Intra-Aortic and Control

How Is DSP Classified?

System, Balloon, Intra-Aortic And Control is FDA product code DSP, Class 2, 21 CFR 870.3535.

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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 194 recalls under this product code since 2003. None was by a company in China. 94 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (22), Process change control (19) and Component design/selection (18). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.