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, Target.

187
Total
187
Cleared
102d
Avg days
1987
Since
187 devices
121–144 of 187
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 Feb 13, 2004
MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K032619
Surgica Corp.
Neurology · 171d
Cleared Feb 04, 2004
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
K033761
Biocompatibles UK Limited
Neurology · 64d
Cleared Feb 04, 2004
MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
K033813
Micrus Corp.
Neurology · 57d
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 Nov 28, 2003
MICRUS MICROCOIL SYSTEM
K032872
Micrus Corp.
Neurology · 74d
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 Aug 01, 2003
GUGLIELMI DETACHABLE COIL (GDC)
K031049
Boston Scientific, Target
Neurology · 121d
Cleared Aug 01, 2003
MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
K031578
Micrus Corp.
Neurology · 73d
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
Cleared May 14, 2003
MATRIX STRETCH RESISTANT DETACHABLE COIL
K031168
Boston Scientific, Target
Neurology · 30d
Cleared Mar 14, 2003
GDC STRETCH RESISTANT DETACHABLE COIL
K030475
Boston Scientific, Target
Neurology · 29d
Cleared Dec 16, 2002
GELSPHERES EMBOLIC AGENT
K023089
Biocure, Inc.
Neurology · 90d
Cleared Oct 22, 2002
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
K022420
Micrus Corp.
Neurology · 90d
Cleared Sep 06, 2002
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
K022735
MicroVention, Inc.
Neurology · 18d