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
49–72 of 114
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
Cleared Sep 02, 2020
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K202182
Imperative Care, Inc.
Neurology · 29d
Cleared Aug 31, 2020
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology
K202251
Penumbra, Inc.
Neurology · 21d
Cleared Jul 21, 2020
Riptide Aspiration System
K201689
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 29d
Cleared Jul 20, 2020
CERENOVUS Large Bore Catheter
K193380
Codman & Shurtleff, Inc.
Neurology · 228d
Cleared Jul 14, 2020
EMBOTRAP III Revascularization Device
K193063
Neuravi, Ltd.
Neurology · 253d
Cleared Feb 27, 2020
Penumbra System Penumbra JET 7X
K191946
Penumbra, Inc.
Neurology · 220d
Cleared Aug 02, 2019
046 Zenith Flex
K190338
Inneuroco, Inc.
Neurology · 169d
Cleared Jul 30, 2019
AXS Vecta Aspiration System
K191768
Stryker Neurovascular
Neurology · 29d
Cleared Jun 16, 2019
Penumbra System Reperfusion Catheter JET 7
K190010
Penumbra, Inc.
Neurology · 164d
Cleared Apr 26, 2019
Penumbra System 3D Revascularization Device
K190464
Penumbra, Inc.
Neurology · 59d
Cleared Apr 24, 2019
AXS Vecta Aspiration System
K190212
Stryker Neurovascular
Neurology · 79d
Cleared Apr 17, 2019
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
K183043
Imperative Care, Inc.
Neurology · 166d
Cleared Mar 13, 2019
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
K183464
Stryker
Neurology · 89d
Cleared Dec 18, 2018
Riptide Aspiration System (Riptide Large Bore Aspiration System)
K183185
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 29d
Cleared Nov 14, 2018
Riptide Aspiration System (React 71 Catheter)
K182101
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 103d
Cleared Oct 25, 2018
074 Zenith Flex System
K181354
Inneuroco, Inc.
Neurology · 156d
Cleared Oct 12, 2018
Penumbra System (Modified 110 Aspiration Tubing)
K182522
Penumbra, Inc.
Neurology · 29d
Cleared Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
K173761
Penumbra, Inc.
Neurology · 249d