Catheter, Ultrasound, Intravascular

What Is It?

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

What Is FDA Product Code OBJ?

Catheter, Ultrasound, Intravascular is FDA product code OBJ, Class 2, 21 CFR 870.1200.

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 1 clearance under this code; the FDA took 114 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 23 recalls under this product code since 2015. None was by a company in China. 3 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (5), Device Design (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.