Introducer, Catheter

How Is DYB Classified?

Introducer, Catheter is FDA product code DYB, Class 2, 21 CFR 870.1340.

How Does It Reach the US Market?

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 11 clearances under this code; the FDA took a median of 143 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 389 recalls under this product code since 2002. None was by a company in China. 56 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (79), Nonconforming Material/Component (64) and Device Design (23). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.