NRY · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1250
Classification
FDA Product Code
NRY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.1250
Review panel
NE
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.