HCG · Class II · 21 CFR 882.5950

FDA Product Code HCG: Device, Neurovascular Embolization

Under FDA product code HCG, neurovascular embolization devices are cleared for the endovascular treatment of intracranial aneurysms and other neurovascular lesions.

These devices — including detachable coils, flow diverters, and intrasaccular implants — are delivered through microcatheters navigated into the cerebral vasculature to occlude aneurysm sacs or redirect blood flow away from the weakened vessel wall, preventing rupture.

HCG devices are Class II medical devices, regulated under 21 CFR 882.5950 and reviewed by the FDA Neurology panel.

Leading manufacturers include MicroVention, Inc., Cordis Neurovascular, Inc. and Boston Scientific Corp.

186
Total
186
Cleared
102d
Avg days
1987
Since
186 devices
73–96 of 186
Cleared Jun 15, 2007
HYDROCOIL EMBOLIC SYSTEM (HES)
K070656
MicroVention, Inc.
Neurology · 98d
Cleared Apr 24, 2007
FX DETACHABLE COIL SYSTEM
K060747
Micro Therapeutics, Inc.
Neurology · 400d
Cleared Dec 07, 2006
THE TRUFILL DCS DETACHABLE COIL SYSTEM
K063254
Cordis Neurovascular, Inc.
Neurology · 41d
Cleared Apr 20, 2006
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
K060625
Micro Therapeutics, Inc.
Neurology · 42d
Cleared Dec 15, 2005
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
K053197
Cordis Neurovascular, Inc.
Neurology · 29d
Cleared Jun 28, 2005
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K050954
MicroVention, Inc.
Neurology · 74d
Cleared Jun 28, 2005
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
K051560
Micro Therapeutics, Inc.
Neurology · 15d
Cleared Jun 22, 2005
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
K051425
Micro Therapeutics, Inc.
Neurology · 21d
Cleared Apr 27, 2005
NEXUS DETACHABLE COIL SYSTEM
K050543
Micro Therapeutics, Inc.
Neurology · 56d
Cleared Apr 15, 2005
MATRIX STRETCH RESISTANT (SR) COILS
K050700
Boston Scientific Corp
Neurology · 28d
Cleared Oct 19, 2004
GDC-10 360 DEGREE COIL SR
K042539
Boston Scientific Corp
Neurology · 29d
Cleared Jul 16, 2004
SAPPHIRE NXT DETACHABLE COIL SYSTEM
K041649
Micro Therapeutics, Inc.
Neurology · 29d
Cleared Jul 07, 2004
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
K041551
MicroVention, Inc.
Neurology · 28d
Cleared Mar 25, 2004
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
K040694
Micro Therapeutics, Inc.
Neurology · 8d
Cleared Jan 09, 2004
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372
Micro Therapeutics, Inc.
Neurology · 79d
Cleared Dec 30, 2003
HYDROCOIL EMBOLIC SYSTEM (HES)
K033836
MicroVention, Inc.
Neurology · 20d
Cleared Oct 22, 2003
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K032590
MicroVention, Inc.
Neurology · 61d
Cleared Sep 25, 2003
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
K032497
Micro Therapeutics, Inc.
Neurology · 43d
Cleared Sep 23, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K032553
Cordis Neurovascular, Inc.
Neurology · 35d
Cleared Sep 23, 2003
CONTOUR SE MICROSPHERES (SYRINGE)
K032707
Boston Scientific Corp
Neurology · 21d
Cleared Sep 16, 2003
MODIFICATION TO CONTOUR SE MICROSPHERES
K032542
Boston Scientific Corp
Neurology · 29d
Cleared Aug 20, 2003
SAPPHIRE DETACHABLE FIBER COILS
K031852
Micro Therapeutics, Inc.
Neurology · 65d
Cleared Jul 21, 2003
SAPPHIRE DETACHABLE COIL SYSTEM
K030392
Micro Therapeutics, Inc.
Neurology · 166d
Cleared Jun 20, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K030963
Cordis Neurovascular, Inc.
Neurology · 85d