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.

117
Total
117
Cleared
130d
Avg days
2004
Since
117 devices
73–96 of 117
Cleared Oct 25, 2018
074 Zenith Flex System
K181354
Inneuroco, Inc.
Neurology · 156d
Cleared Oct 12, 2018
Penumbra System (Modified 110 Aspiration Tubing)
K182522
Penumbra, Inc.
Neurology · 29d
Cleared Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
K173761
Penumbra, Inc.
Neurology · 249d
Cleared Jul 04, 2018
Riptide Aspiration System React 68 Catheter
K180705
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 107d
Cleared Jun 20, 2018
Penumbra System
K180008
Penumbra, Inc.
Neurology · 169d
Cleared Jun 11, 2018
SOFIA Plus Aspiration Catheter
K173200
MicroVention, Inc.
Neurology · 252d
Cleared May 09, 2018
EmboTrap ll Revascularization Device
K173452
Neuravi, Ltd.
Neurology · 184d
Cleared Apr 19, 2018
Zenith Flex System
K172167
Inneuroco, Inc.
Neurology · 275d
Cleared Mar 18, 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
K173841
Stryker
Neurology · 90d
Cleared Dec 21, 2017
Riptide Aspiration System
K172448
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 129d
Cleared Apr 20, 2017
Penumbra 3D Revascularization Device
K162901
Penumbra, Inc.
Neurology · 185d
Cleared Mar 08, 2017
Solitaire Platinum Revascularization Device, 6x40 mm
K160641
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 366d
Cleared Sep 21, 2016
Solitaire Platinum Revascularization Device
K161879
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 75d
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 Dec 23, 2015
Solitaire Platinum Revascularization Device
K153071
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 62d
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 Feb 05, 2015
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
K141516
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 241d
Cleared Oct 22, 2014
SOLITAIRE 2 REVASCULARIZATION DEVICE
K141491
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 139d