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
110 devices
Cleared
Mar 18, 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
Stryker
Neurology
90d
Cleared
Apr 20, 2017
Penumbra 3D Revascularization Device
Penumbra, Inc.
Neurology
185d
Cleared
Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
Penumbra, Inc.
Neurology
28d
Cleared
Jun 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
Penumbra, Inc.
Neurology
58d
Cleared
May 25, 2016
Penumbra System, Penumbra Pump MAX
Penumbra, Inc.
Neurology
97d
Cleared
Jan 13, 2016
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
Penumbra, Inc.
Neurology
131d
Cleared
Aug 06, 2015
Penumbra System 110 Aspiration Tubing
Penumbra, Inc.
Neurology
51d
Cleared
Jun 12, 2015
Trevo XP ProVue Retriever (4x30mm)
Concentric Medical, Inc.
Neurology
94d
Cleared
May 22, 2015
Penumbra System ACE
Penumbra, Inc.
Neurology
262d
Cleared
Apr 06, 2015
Trevo XP ProVue Retriever (6X25mm)
Concentric Medical, Inc.
Neurology
161d
Cleared
May 13, 2014
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
Penumbra, Inc.
Neurology
197d
Cleared
Jan 17, 2014
MODIFIED TREVO PROVUE RETRIEVER
Concentric Medical, Inc.
Neurology
66d
Cleared
Jan 13, 2014
MODIFIED TREVO PROVUE RETRIEVER
Concentric Medical, Inc.
Neurology
140d
Cleared
Oct 31, 2012
MODIFIED TREVO RETRIEVER
Concentric Medical, Inc.
Neurology
78d
Cleared
Aug 03, 2012
TREVO RETRIEVER
Concentric Medical, Inc.
Neurology
126d
Cleared
Nov 23, 2011
PENUMBRA SYSTEM MAX
Penumbra, Inc.
Neurology
28d
Cleared
Feb 17, 2011
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
Concentric Medical, Inc.
Neurology
454d
Cleared
May 21, 2010
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
Penumbra, Inc.
Neurology
64d
Cleared
Sep 21, 2009
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054
Penumbra, Inc.
Neurology
185d
Cleared
Feb 12, 2009
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
Concentric Medical, Inc.
Neurology
30d
Cleared
Aug 15, 2008
MODIFICATION TO MERCI RETRIEVER
Concentric Medical, Inc.
Neurology
29d
Cleared
Jun 05, 2008
MERCI RETRIEVER
Concentric Medical, Inc.
Neurology
28d
Cleared
Dec 28, 2007
PENUMBRA SYSTEM
Penumbra, Inc.
Neurology
94d
Cleared
Aug 22, 2007
MODIFIED MERCI RETRIEVER, MODEL 90060
Concentric Medical, Inc.
Neurology
117d