Oxygenator, Cardiopulmonary Bypass

How Is DTZ Classified?

Oxygenator, Cardiopulmonary Bypass is FDA product code DTZ, Class 2, 21 CFR 870.4350.

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 1 clearance under this code; the FDA took 105 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 107 recalls under this product code since 2004. None was by a company in China. 3 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (24), Process control (12) and Device Design (12). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.