Catheter, Percutaneous, Neurovasculature

What Is It?

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

What Is FDA Product Code QJP?

Catheter, Percutaneous, Neurovasculature is FDA product code QJP, 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 6 clearances under this code; the FDA took a median of 258 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 7 recalls under this product code since 2023. 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 (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.