Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

What Is It?

To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.

What Is FDA Product Code NWX?

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring is FDA product code NWX, Class 3.

How Does It Reach the US Market?

A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. 1 approval under this code is held by a Chinese applicant.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Process control (2) and Process design (1).

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