FDA Product Code NRY: Catheter, Thrombus Retriever
Rapid restoration of blood flow is the priority in ischemic stroke treatment. FDA product code NRY covers thrombus retriever catheters for neurovascular use.
These devices are advanced through the cerebral vasculature to engage and retrieve blood clots from occluded intracranial arteries, restoring perfusion to ischemic brain tissue. Mechanical thrombectomy with NRY devices has transformed outcomes for large vessel occlusion stroke.
NRY devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Neurology panel.
Leading manufacturers include Penumbra, Inc., Perfuze, Ltd. and Alembic, LLC.
FDA 510(k) Cleared Catheter, Thrombus Retriever Devices (Product Code NRY)
About Product Code NRY - Regulatory Context
510(k) Submission Activity
106 total 510(k) submissions under product code NRY since 2004, with 106 receiving FDA clearance (average review time: 128 days).
Submission volume has increased in recent years - 23 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for NRY submissions have been consistent, averaging 130 days recently vs 127 days historically.
NRY devices are reviewed by the Neurology panel. Browse all Neurology devices →