Catheter, Thrombus Retriever

What Is It?

The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.

How Is NRY Classified?

Catheter, Thrombus Retriever is FDA product code NRY, 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 1 clearance under this code; the FDA took 266 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 26 recalls under this product code since 2010. None was by a company in China. 9 are Class I, the most serious grade.

The root causes the FDA records most often are Process design (6), Packaging process control (5) and Process control (4). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.