NRY · Class II · 21 CFR 870.1250

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., Concentric Medical, Inc. and Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

114
Total
114
Cleared
130d
Avg days
2004
Since
114 devices
25–48 of 114
Cleared Feb 13, 2025
Penumbra System (Reperfusion Catheter RED 72)
K242104
Penumbra, Inc.
Neurology · 210d
Cleared Jan 14, 2025
Zoom System
K242672
Imperative Care, Inc.
Neurology · 130d
Cleared Oct 29, 2024
Riptide Aspiration System
K243080
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 29d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241221
Cerenovus, Inc.
Neurology · 168d
Cleared Oct 01, 2024
Esperance 3+ Aspiration Catheter System
K240917
Wallaby Medical
Neurology · 181d
Cleared Sep 20, 2024
Millipede 088 Access Catheter
K242504
Perfuze, Ltd.
Neurology · 29d
Cleared Jul 02, 2024
Next Generation Aspiration Catheter
K234083
Balt USA, LLC
Neurology · 193d
Cleared Apr 23, 2024
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
K233329
Route 92 Medical, Inc.
Neurology · 207d
Cleared Feb 29, 2024
APRO 55 Catheter and Alembic Aspiration Tubing
K232971
Alembic, LLC
Neurology · 161d
Cleared Jan 17, 2024
Cerenovus Large Bore Catheter
K233988
Cerenovus, Inc.
Neurology · 30d
Cleared Oct 18, 2023
Millipede 070 Aspiration Catheter
K232524
Perfuze, Ltd.
Neurology · 61d
Cleared Sep 20, 2023
Socrates Aspiration System
K223913
Scientia Vascular, Inc.
Neurology · 265d
Cleared Aug 25, 2023
072 Aspiration System
K222786
Q'Apel Medical, Inc.
Neurology · 344d
Cleared Apr 17, 2023
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
K230429
Rapid Medical , Ltd.
Neurology · 59d
Cleared Apr 11, 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
K223530
Route 92 Medical, Inc.
Neurology · 139d
Cleared Apr 10, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K230695
Alembic, LLC
Neurology · 28d
Cleared Mar 09, 2023
CEREGLIDE 71 Intermediate Catheter
K221934
Cerenovus, Inc.
Neurology · 251d
Cleared Feb 17, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K223545
Alembic, LLC
Neurology · 84d
Cleared Dec 20, 2022
Penumbra System (Reperfusion Catheter RED 43)
K222808
Penumbra, Inc.
Neurology · 95d
Cleared Jul 25, 2022
Tigertriever 13 Revascularization Device
K220808
Rapid Medical , Ltd.
Neurology · 129d
Cleared Mar 31, 2022
ERIC Retrieval Device
K211120
MicroVention, Inc.
Neurology · 350d
Cleared Nov 16, 2021
Esperance Aspiration Catheter System
K211697
Wallaby Medical
Neurology · 166d
Cleared Oct 13, 2021
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
K212908
Neuravi, Ltd.
Neurology · 30d
Cleared Aug 16, 2021
Penumbra System (Reperfusion Catheter RED 72)
K211654
Penumbra, Inc.
Neurology · 80d