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 Imperative Care, Inc..

110
Total
110
Cleared
133d
Avg days
2004
Since
Growing category - 26 submissions in the last 2 years vs 13 in the prior period
Review times increasing: avg 148d recently vs 128d historically

FDA 510(k) Cleared Catheter, Thrombus Retriever Devices (Product Code NRY)

110 devices
1–24 of 110
Cleared Jun 10, 2026
Penumbra System (Thunderbolt Aspiration Tubing)
K250690
Penumbra, Inc.
Neurology · 460d
Cleared May 20, 2026
Zenith Aspiration Catheter
K252707
Suzhou Zenith Vascular SciTech Limited
Neurology · 266d
Cleared May 07, 2026
Lynx Aspiration Catheter System
K254276
Q'Apel Medical, Inc.
Neurology · 128d
Cleared Mar 16, 2026
Millipede System
K253590
Perfuze, Ltd.
Neurology · 119d
Cleared Mar 12, 2026
Tigertriever 25 Revascularization Device
K253062
Rapid Medical , Ltd.
Neurology · 171d
Cleared Jan 15, 2026
Esperance pHLO Aspiration System
K251357
Phenox, Ltd.
Neurology · 260d
Cleared Nov 10, 2025
NeVasc Aspiration System
K251006
Vesalio, Inc.
Neurology · 223d
Cleared Oct 30, 2025
Zoom System (Zoom 4S Catheter)
K252046
Imperative Care, Inc.
Neurology · 122d
Cleared Oct 06, 2025
Tigertriever 17 Ultra Revascularization Device
K251603
Rapid Medical , Ltd.
Neurology · 132d
Cleared Sep 25, 2025
EMBOTRAP III Revascularization Device
K251789
Neuravi Limited
Neurology · 106d
Cleared Aug 29, 2025
Millipede70 Aspiration Catheter
K252392
Perfuze, Ltd.
Neurology · 29d
Cleared Aug 22, 2025
CEREGLIDE 71 Catheter System
K251828
Cerenovus, Inc.
Neurology · 70d
Cleared Jun 03, 2025
Raptor Aspiration Catheter
K243948
Balt USA, LLC
Neurology · 162d
Cleared May 28, 2025
Zoom 7X Catheter
K243047
Imperative Care, Inc.
Neurology · 243d
Cleared May 19, 2025
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
K243601
Route 92 Medical, Inc.
Neurology · 179d
Cleared Apr 30, 2025
APRO 45 Catheter and Alembic Aspiration Tubing
K251015
Alembic, LLC
Neurology · 28d
Cleared Apr 28, 2025
APRO 55 Swift Catheter and Alembic Aspiration Tubing
K250958
Alembic, LLC
Neurology · 28d
Cleared Feb 26, 2025
Millipede 070 Aspiration Catheter
K250012
Perfuze, Ltd.
Neurology · 55d
Cleared Feb 24, 2025
APRO 70 Swift Catheter and Alembic Aspiration Tubing
K243287
Alembic, LLC
Neurology · 129d
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

About Product Code NRY - Regulatory Context

510(k) Submission Activity

110 total 510(k) submissions under product code NRY since 2004, with 110 receiving FDA clearance (average review time: 133 days).

Submission volume has increased in recent years - 26 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NRY Product Code

Recent submissions under NRY have taken an average of 148 days to reach a decision - up from 128 days historically. Manufacturers should account for longer review timelines in current project planning.

NRY devices are reviewed by the Neurology panel. Browse all Neurology devices →