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)
Top companies in HCG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Mar 21, 2016 | Stryker 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 |
HCG | K042539 |
| Mar 21, 2016 | Stryker 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 |
HCG | K042539 |
| Dec 16, 2014 | Stryker 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 |
HCG | K120850 |
| Dec 16, 2014 | Stryker 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 |
HCG | K103355 |
| Dec 16, 2014 | Stryker 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 |
HCG | K103355 |
| Dec 16, 2014 | Stryker 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 |
HCG | K103355 |
| Dec 13, 2013 | Stryker 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 |
HCG | None listed |
| Dec 13, 2013 | Stryker 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 |
HCG | K030475 |
| Jan 26, 2012 | Micro 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 |
HCG | K060747 K081465 |
| Jan 24, 2012 | Micro 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 |
HCG | K060747 |
| Apr 12, 2011 | Penumbra 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 |
HCG | K103305 |
| Jan 3, 2011 | Micrus 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 |
HCG | K062036 K072173 +1 |
| Sep 16, 2008 | Cook, 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 |
HCG | K901337 |
| Sep 16, 2008 | Cook, 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 |
HCG | K901337 |
| Mar 29, 2007 | Boston 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 |
HCG | K050700 |
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