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
Nov 30, 2012
SOLITAIRE 2 REVASCULARIZATION DEVICE
Micro Therapeutics Dba Ev3 Neurovascular
Neurology
29d
Cleared
Oct 31, 2012
MODIFIED TREVO RETRIEVER
Concentric Medical, Inc.
Neurology
78d
Cleared
Aug 03, 2012
TREVO RETRIEVER
Concentric Medical, Inc.
Neurology
126d
Cleared
Mar 02, 2012
SOLITAIRE FR REVASCULARIZATION DEVICE
Micro Therapeutics Dba Ev3 Neurovascular
Neurology
102d
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
Cleared
Apr 24, 2007
MODIFIED MERCY RETRIEVER, MODEL 90070
Concentric Medical, Inc.
Neurology
60d
Cleared
Jan 24, 2007
MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
Concentric Medical, Inc.
Neurology
34d
Cleared
Jan 19, 2007
MODIFIED MERCI RETRIEVER, MODEL 90050
Concentric Medical, Inc.
Neurology
184d
Cleared
May 25, 2006
MODIFIED MERCI RETRIEVER, MODEL 90092
Concentric Medical, Inc.
Neurology
38d
Cleared
Aug 11, 2004
MERCI RETRIEVER, MODELS 90065, 90066
Concentric Medical, Inc.
Neurology
257d