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
97–114 of 114
Cleared Nov 30, 2012
SOLITAIRE 2 REVASCULARIZATION DEVICE
K123378
Micro Therapeutics Dba Ev3 Neurovascular
Neurology · 29d
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 Mar 02, 2012
SOLITAIRE FR REVASCULARIZATION DEVICE
K113455
Micro Therapeutics Dba Ev3 Neurovascular
Neurology · 102d
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
Cleared Apr 24, 2007
MODIFIED MERCY RETRIEVER, MODEL 90070
K070521
Concentric Medical, Inc.
Neurology · 60d
Cleared Jan 24, 2007
MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
K063774
Concentric Medical, Inc.
Neurology · 34d
Cleared Jan 19, 2007
MODIFIED MERCI RETRIEVER, MODEL 90050
K062046
Concentric Medical, Inc.
Neurology · 184d
Cleared May 25, 2006
MODIFIED MERCI RETRIEVER, MODEL 90092
K061059
Concentric Medical, Inc.
Neurology · 38d
Cleared Aug 11, 2004
MERCI RETRIEVER, MODELS 90065, 90066
K033736
Concentric Medical, Inc.
Neurology · 257d