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
110 devices
73–96 of 110
Cleared Mar 18, 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
K173841
Stryker
Neurology · 90d
Cleared Apr 20, 2017
Penumbra 3D Revascularization Device
K162901
Penumbra, Inc.
Neurology · 185d
Cleared Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161640
Penumbra, Inc.
Neurology · 28d
Cleared Jun 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161064
Penumbra, Inc.
Neurology · 58d
Cleared May 25, 2016
Penumbra System, Penumbra Pump MAX
K160449
Penumbra, Inc.
Neurology · 97d
Cleared Jan 13, 2016
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
K152541
Penumbra, Inc.
Neurology · 131d
Cleared Aug 06, 2015
Penumbra System 110 Aspiration Tubing
K151623
Penumbra, Inc.
Neurology · 51d
Cleared Jun 12, 2015
Trevo XP ProVue Retriever (4x30mm)
K150616
Concentric Medical, Inc.
Neurology · 94d
Cleared May 22, 2015
Penumbra System ACE
K142458
Penumbra, Inc.
Neurology · 262d
Cleared Apr 06, 2015
Trevo XP ProVue Retriever (6X25mm)
K143077
Concentric Medical, Inc.
Neurology · 161d
Cleared May 13, 2014
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
K133317
Penumbra, Inc.
Neurology · 197d
Cleared Jan 17, 2014
MODIFIED TREVO PROVUE RETRIEVER
K133464
Concentric Medical, Inc.
Neurology · 66d
Cleared Jan 13, 2014
MODIFIED TREVO PROVUE RETRIEVER
K132641
Concentric Medical, Inc.
Neurology · 140d
Cleared Oct 31, 2012
MODIFIED TREVO RETRIEVER
K122478
Concentric Medical, Inc.
Neurology · 78d
Cleared Aug 03, 2012
TREVO RETRIEVER
K120961
Concentric Medical, Inc.
Neurology · 126d
Cleared Nov 23, 2011
PENUMBRA SYSTEM MAX
K113163
Penumbra, Inc.
Neurology · 28d
Cleared Feb 17, 2011
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
K093610
Concentric Medical, Inc.
Neurology · 454d
Cleared May 21, 2010
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
K100769
Penumbra, Inc.
Neurology · 64d
Cleared Sep 21, 2009
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054
K090752
Penumbra, Inc.
Neurology · 185d
Cleared Feb 12, 2009
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
K090085
Concentric Medical, Inc.
Neurology · 30d
Cleared Aug 15, 2008
MODIFICATION TO MERCI RETRIEVER
K082034
Concentric Medical, Inc.
Neurology · 29d
Cleared Jun 05, 2008
MERCI RETRIEVER
K081305
Concentric Medical, Inc.
Neurology · 28d
Cleared Dec 28, 2007
PENUMBRA SYSTEM
K072718
Penumbra, Inc.
Neurology · 94d
Cleared Aug 22, 2007
MODIFIED MERCI RETRIEVER, MODEL 90060
K071172
Concentric Medical, Inc.
Neurology · 117d