Catheter, Percutaneous, Cutting/Scoring

What Is It?

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

How Is PNO Classified?

Catheter, Percutaneous, Cutting/Scoring is FDA product code PNO, Class 2, 21 CFR 870.1250.

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. Chinese applicants hold 3 clearances under this code; the FDA took a median of 225 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2019. None was by a company in China. 3 are Class I, the most serious grade.

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.