Dilator, Vessel, for Percutaneous Catheterization

How Is DRE Classified?

Dilator, Vessel, For Percutaneous Catheterization is FDA product code DRE, Class 2, 21 CFR 870.1310.

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 1 clearance under this code; the FDA took 193 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 40 recalls under this product code since 2004. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process control (17), Packaging process control (3) and Mixed-up of materials/components (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.