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., Imperative Care, Inc. and Alembic, LLC.

108
Total
108
Cleared
129d
Avg days
2004
Since
108 devices
25–48 of 108
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
Cleared Jul 30, 2021
EMBOTRAP III Revascularization Device
K211338
Neuravi, Ltd.
Neurology · 88d
Cleared Jul 01, 2021
Penumbra System (RED 68 Reperfusion Catheter)
K211411
Penumbra, Inc.
Neurology · 56d
Cleared Jun 08, 2021
ZOOM 71 Reperfusion Catheter
K211476
Imperative Care, Inc.
Neurology · 27d
Cleared May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
K203440
Penumbra, Inc.
Neurology · 178d
Cleared Apr 23, 2021
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K210996
Imperative Care, Inc.
Neurology · 21d
Cleared Mar 23, 2021
Tigertriever and Tigertriever 17 Revascularization Devce
K203592
Rapid Medical , Ltd.
Neurology · 105d