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 04, 2018
Riptide Aspiration System React 68 Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
107d
Cleared
Jun 20, 2018
Penumbra System
Penumbra, Inc.
Neurology
169d
Cleared
Jun 11, 2018
SOFIA Plus Aspiration Catheter
MicroVention, Inc.
Neurology
252d
Cleared
May 09, 2018
EmboTrap ll Revascularization Device
Neuravi, Ltd.
Neurology
184d
Cleared
Apr 19, 2018
Zenith Flex System
Inneuroco, Inc.
Neurology
275d
Cleared
Mar 18, 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
Stryker
Neurology
90d
Cleared
Dec 21, 2017
Riptide Aspiration System
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
129d
Cleared
Apr 20, 2017
Penumbra 3D Revascularization Device
Penumbra, Inc.
Neurology
185d
Cleared
Mar 08, 2017
Solitaire Platinum Revascularization Device, 6x40 mm
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
366d
Cleared
Sep 21, 2016
Solitaire Platinum Revascularization Device
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
75d
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
Dec 23, 2015
Solitaire Platinum Revascularization Device
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
62d
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
Feb 05, 2015
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
241d
Cleared
Oct 22, 2014
SOLITAIRE 2 REVASCULARIZATION DEVICE
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
139d
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