Device type

Catheter, Thrombus Retriever

Product code NRY · Class II · 21 CFR 870.1250 · Cardiovascular

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.

FDA classification database