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
Cleared
Jul 30, 2021
EMBOTRAP III Revascularization Device
Neuravi, Ltd.
Neurology
88d
Cleared
Jul 01, 2021
Penumbra System (RED 68 Reperfusion Catheter)
Penumbra, Inc.
Neurology
56d
Cleared
Jun 08, 2021
ZOOM 71 Reperfusion Catheter
Imperative Care, Inc.
Neurology
27d
Cleared
May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
Penumbra, Inc.
Neurology
178d
Cleared
Apr 23, 2021
ZOOM (71, 55, 45, 35) Reperfusion Catheters
Imperative Care, Inc.
Neurology
21d
Cleared
Mar 23, 2021
Tigertriever and Tigertriever 17 Revascularization Devce
Rapid Medical , Ltd.
Neurology
105d
Cleared
Sep 02, 2020
ZOOM (71, 55, 45, 35) Reperfusion Catheters
Imperative Care, Inc.
Neurology
29d
Cleared
Aug 31, 2020
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology
Penumbra, Inc.
Neurology
21d
Cleared
Jul 21, 2020
Riptide Aspiration System
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
29d
Cleared
Jul 20, 2020
CERENOVUS Large Bore Catheter
Codman & Shurtleff, Inc.
Neurology
228d
Cleared
Jul 14, 2020
EMBOTRAP III Revascularization Device
Neuravi, Ltd.
Neurology
253d
Cleared
Feb 27, 2020
Penumbra System Penumbra JET 7X
Penumbra, Inc.
Neurology
220d
Cleared
Aug 02, 2019
046 Zenith Flex
Inneuroco, Inc.
Neurology
169d
Cleared
Jul 30, 2019
AXS Vecta Aspiration System
Stryker Neurovascular
Neurology
29d
Cleared
Jun 16, 2019
Penumbra System Reperfusion Catheter JET 7
Penumbra, Inc.
Neurology
164d
Cleared
Apr 26, 2019
Penumbra System 3D Revascularization Device
Penumbra, Inc.
Neurology
59d
Cleared
Apr 24, 2019
AXS Vecta Aspiration System
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
Imperative Care, Inc.
Neurology
166d
Cleared
Mar 13, 2019
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
Stryker
Neurology
89d
Cleared
Dec 18, 2018
Riptide Aspiration System (Riptide Large Bore Aspiration System)
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
29d
Cleared
Nov 14, 2018
Riptide Aspiration System (React 71 Catheter)
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
103d
Cleared
Oct 25, 2018
074 Zenith Flex System
Inneuroco, Inc.
Neurology
156d
Cleared
Oct 12, 2018
Penumbra System (Modified 110 Aspiration Tubing)
Penumbra, Inc.
Neurology
29d
Cleared
Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
Penumbra, Inc.
Neurology
249d