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
49–72 of 186
Cleared Sep 29, 2011
HYDROCOIL EMBOLIC SYSTEM (HES)
K112226
MicroVention, Inc.
Neurology · 57d
Cleared Sep 20, 2011
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
K111451
MicroVention, Inc.
Neurology · 118d
Cleared Apr 28, 2011
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
K103758
MicroVention, Inc.
Neurology · 126d
Cleared Feb 16, 2011
GDC 360 DETEACHABLE COIL
K103355
Boston Scientific Corp
Neurology · 92d
Cleared Jan 26, 2011
PENUMBRA EMBOLIZATION COIL SYSTEM
K103305
Penumbra, Inc.
Neurology · 78d
Cleared Dec 10, 2010
INZONE DETACHMENT SYSTEM
K103008
Boston Scientific Corp
Neurology · 59d
Cleared Oct 15, 2010
TARGET DETACHABLE COIL
K102672
Boston Scientific Corp
Neurology · 29d
Cleared May 26, 2010
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K093973
Codman & Shurtleff, Inc.
Neurology · 153d
Cleared Apr 22, 2010
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
K100454
MicroVention, Inc.
Neurology · 64d
Cleared Feb 04, 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
K093142
Boston Scientific Corp
Neurology · 122d
Cleared Jan 21, 2010
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
K093919
MicroVention, Inc.
Neurology · 30d
Cleared Jan 15, 2010
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
K093358
MicroVention, Inc.
Neurology · 79d
Cleared Sep 30, 2009
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
K092666
Boston Scientific Corp
Neurology · 30d
Cleared Jun 30, 2009
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
K091641
MicroVention, Inc.
Neurology · 26d
Cleared Jun 22, 2009
MICROPLEX COIL SYSTEM-COSMOS
K090891
MicroVention, Inc.
Neurology · 84d
Cleared Apr 10, 2009
HYDROFRAME (HES)
K090357
MicroVention, Inc.
Neurology · 57d
Cleared Mar 12, 2009
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
K090168
MicroVention, Inc.
Neurology · 48d
Cleared Mar 05, 2009
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
K090001
MicroVention, Inc.
Neurology · 62d
Cleared Oct 02, 2008
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
K082461
MicroVention, Inc.
Neurology · 36d
Cleared Sep 12, 2008
TRUFILL DCS SYRINGE
K082324
Cordis Neurovascular, Inc.
Neurology · 29d
Cleared Jul 11, 2008
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
K080666
MicroVention, Inc.
Neurology · 123d
Cleared May 02, 2008
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
K080967
Cordis Neurovascular, Inc.
Neurology · 28d
Cleared Sep 26, 2007
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
K071962
Cordis Neurovascular, Inc.
Neurology · 72d
Cleared Jul 12, 2007
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634
Boston Scientific Corp
Neurology · 27d