Balloon Aortic Valvuloplasty

What Is It?

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.

What Is FDA Product Code OZT?

Balloon Aortic Valvuloplasty is FDA product code OZT, Class 2, 21 CFR 870.1255.

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 113 days from receipt to decision on them. 2 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Process design (1) and Nonconforming Material/Component (1).

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