Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

What Is FDA Product Code DTL?

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass is FDA product code DTL, Class 2, 21 CFR 870.4290.

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

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 59 recalls under this product code since 2006. None was by a company in China. 6 are Class I, the most serious grade.

The root causes the FDA records most often are Packaging process control (24), Process control (8) and Equipment maintenance (6). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.