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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2013 | K132952 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Oct 10, 2013 | K132482 | BARRICADE EMBOLIZATION COIL SYSTEM Blockade Medical | HCG |
| Oct 4, 2013 | K131948 | MICROPLEX COIL SYSTEM (MCS) MicroVention, Inc. | HCG |
| Sep 20, 2013 | K132317 | MICROPLEX COIL SYSTEM (MCS), VFC MicroVention, Inc. | HCG |
| Jul 25, 2013 | K131475 | BARRICADE EMBOLIZATION COIL SYSTEM Blockade Medical | HCG |
| Mar 28, 2013 | K123338 | BARRICADE EMBOLIZATION COIL SYSTEM Blockade Medical | HCG |
| Jan 25, 2013 | K123560 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM Codman & Shurtleff, Inc. | HCG |
| Nov 30, 2012 | K123377 | TARGET DETACHABLE COIL Stryker Neurovascular | HCG |
| Apr 25, 2012 | K120908 | HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Apr 17, 2012 | K120850 | TARGET DETACHABLE COIL Stryker Neurovascular | HCG |
| Apr 4, 2012 | K120686 | ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM Codman & Shurtleff, Inc. | HCG |
| Apr 2, 2012 | K120330 | PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 Penumbra, Inc. | HCG |
| Mar 8, 2012 | K113822 | QUADRASPHERE 30 TO 60 Biosphere Medical, Inc. | HCG |
| Mar 2, 2012 | K120274 | DELTAMAXX 18 MICROCOIL SYSTEM Codman and Shurtleff, Inc. | HCG |
| Dec 16, 2011 | K113457 | HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Dec 13, 2011 | K113412 | TARGET DETACHABLE COIL Stryker Neurovascular | HCG |
| Dec 1, 2011 | K112181 | HYDROCOIL(R) EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Sep 29, 2011 | K112226 | HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Sep 20, 2011 | K111451 | MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX MicroVention, Inc. | HCG |
| Sep 15, 2011 | K112385 | TRAGET DETACHABLE COIL Stryker Neurovascular | HCG |
| Apr 28, 2011 | K103758 | MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 MicroVention, Inc. | HCG |
| Feb 16, 2011 | K103355 | GDC 360 DETEACHABLE COIL Boston Scientific Corp | HCG |
| Jan 26, 2011 | K103305 | PENUMBRA EMBOLIZATION COIL SYSTEM Penumbra, Inc. | HCG |
| Dec 10, 2010 | K103008 | INZONE DETACHMENT SYSTEM Boston Scientific Corp | HCG |
| Oct 15, 2010 | K102672 | TARGET DETACHABLE COIL Boston Scientific Corp | HCG |
| May 26, 2010 | K093973 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Codman & Shurtleff, Inc. | HCG |
| Apr 22, 2010 | K100454 | HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V MicroVention, Inc. | HCG |
| Apr 16, 2010 | K094018 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES Biocompatibles UK Limited | HCG |
| Feb 4, 2010 | K093142 | TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM Boston Scientific Corp | HCG |
| Jan 21, 2010 | K093919 | MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V MicroVention, Inc. | HCG |
| Jan 15, 2010 | K093358 | MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V MicroVention, Inc. | HCG |
| Sep 30, 2009 | K092666 | INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 Boston Scientific Corp | HCG |
| Jun 30, 2009 | K091641 | HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) MicroVention, Inc. | HCG |
| Jun 22, 2009 | K090891 | MICROPLEX COIL SYSTEM-COSMOS MicroVention, Inc. | HCG |
| Apr 10, 2009 | K090357 | HYDROFRAME (HES) MicroVention, Inc. | HCG |
| Mar 12, 2009 | K090168 | AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 MicroVention, Inc. | HCG |
| Mar 5, 2009 | K090001 | V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 MicroVention, Inc. | HCG |
| Jan 2, 2009 | K083646 | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL Micrus Endovascular Corporation | HCG |
| Oct 17, 2008 | K082739 | MICRUS MICROCOIL DELIVERY SYSTEM Micrus Endovascular Corporation | HCG |
| Oct 2, 2008 | K082461 | BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B MicroVention, Inc. | HCG |
| Sep 12, 2008 | K082324 | TRUFILL DCS SYRINGE Cordis Neurovascular, Inc. | HCG |
| Jul 11, 2008 | K080666 | HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS MicroVention, Inc. | HCG |
| Jun 30, 2008 | K080379 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT Micrus Endovascular Corporation | HCG |
| May 8, 2008 | K080437 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF Micrus Endovascular Corporation | HCG |
| May 2, 2008 | K080967 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT Cordis Neurovascular, Inc. | HCG |
| Feb 26, 2008 | K073442 | MICRUS MICROCOIL SYSTEMS Micrus Endovascular Corporation | HCG |
| Feb 14, 2008 | K073419 | PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES Rj Medical, Inc. | HCG |
| Oct 5, 2007 | K072173 | MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC Micrus Endovascular Corporation | HCG |
| Sep 26, 2007 | K071962 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) Cordis Neurovascular, Inc. | HCG |
| Jul 12, 2007 | K071634 | MODIFICATION TO:CONTOUR SE MICROSPHERES Boston Scientific Corp | HCG |
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