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Panels › Neurology › Product code HCG · Class 2

Device, Neurovascular Embolization

Regulation 882.5950

5510(k)s in 12 months (187 all time)
2recalls in 12 months (68 all time)
67recalls that name a 510(k)
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Top companies in HCG

DateFirm and productCodeLinked 510(k)
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormaliti
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormaliti
Terminated
HCGK113412
K153658
Mar 21, 2016Stryker Neurovascular
GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms thata because of
Terminated
HCGK042539
Mar 21, 2016Stryker Neurovascular
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because o
Terminated
HCGK042539
Dec 16, 2014Stryker Neurovascular
Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target D
Terminated
HCGK120850
Dec 16, 2014Stryker Neurovascular
GDC-18 360 20mm x 33cm ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical co
Terminated
HCGK103355
Dec 16, 2014Stryker Neurovascular
GDC-10 360 10mm x 30cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical
Terminated
HCGK103355
Dec 16, 2014Stryker Neurovascular
GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medi
Terminated
HCGK103355
Dec 13, 2013Stryker Neurovascular
Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL
Terminated
HCGNone listed
Dec 13, 2013Stryker Neurovascular
Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsio
Terminated
HCGK030475
Jan 26, 2012Micro Therapeutics Inc, dba ev3 Neurovascular
Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as
Terminated
HCGK060747
K081465
Jan 24, 2012Micro Therapeutics Inc, dba ev3 Neurovascular
Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque posit
Terminated
HCGK060747
Apr 12, 2011Penumbra Inc.
Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endov
Terminated
HCGK103305
Jan 3, 2011Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131
Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each compo
Terminated
HCGK062036
K072173 +1
Sep 16, 2008Cook, Inc.
Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.
Terminated
HCGK901337
Sep 16, 2008Cook, Inc.
Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.
Terminated
HCGK901337
Mar 29, 2007Boston Scientific Target
Matrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog Number: 494203, UPN: M0034942030, Distributed and Manufactured by Boston Scientific Co
Terminated
HCGK050700

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