FDA 510(k) Applications Submitted by MicroVention, Inc.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K083343 |
11/13/2008 |
HEADWAY 17 MICROCATHETER |
MICROVENTION, INC. |
K214024 |
12/22/2021 |
SOFIA 88 Catheter |
MicroVention, Inc. |
K192684 |
09/26/2019 |
HydroPearl Microspheres |
MicroVention, Inc. |
K130577 |
03/05/2013 |
AZUR PUSHABLE 18 & 35 SYSTEM |
MICROVENTION, INC. |
K122316 |
08/01/2012 |
AZUR DETACHABLE 35 |
MICROVENTION, INC. |
K123384 |
11/02/2012 |
AZUR CX DETACHABLE 18 |
MICROVENTION, INC. |
K090168 |
01/23/2009 |
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 |
MICROVENTION, INC. |
K090357 |
02/12/2009 |
HYDROFRAME (HES) |
MICROVENTION, INC. |
K082385 |
08/19/2008 |
CHAPERON GUIDING CATHETER |
MICROVENTION, INC. |
K082461 |
08/27/2008 |
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B |
MICROVENTION, INC. |
K222694 |
09/06/2022 |
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) |
MicroVention, Inc. |
K080666 |
03/10/2008 |
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS |
MICROVENTION, INC. |
K080863 |
03/28/2008 |
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE |
MICROVENTION, INC. |
K100454 |
02/17/2010 |
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V |
MICROVENTION, INC. |
K120908 |
03/26/2012 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K111307 |
05/10/2011 |
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM |
MICROVENTION, INC. |
K111451 |
05/25/2011 |
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX |
MICROVENTION, INC. |
K131948 |
06/27/2013 |
MICROPLEX COIL SYSTEM (MCS) |
MICROVENTION, INC. |
K132317 |
07/25/2013 |
MICROPLEX COIL SYSTEM (MCS), VFC |
MICROVENTION, INC. |
K112226 |
08/03/2011 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K102365 |
08/20/2010 |
MICROPLEX COIL SYSTEM- COSMOS |
MICROVENTION, INC. |
K122543 |
08/21/2012 |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
MICROVENTION, INC. |
K132952 |
09/19/2013 |
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K093358 |
10/28/2009 |
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V |
MICROVENTION, INC. |
K113457 |
11/22/2011 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K133626 |
11/26/2013 |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
MICROVENTION, INC. |
K153594 |
12/16/2015 |
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) |
MICROVENTION, INC. |
K093919 |
12/22/2009 |
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V |
MICROVENTION, INC. |
K103758 |
12/23/2010 |
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 |
MICROVENTION, INC. |
K230775 |
03/21/2023 |
SOFIA EX Intracranial Support Catheter |
MicroVention, Inc. |
K090001 |
01/02/2009 |
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 |
MICROVENTION, INC. |
K150366 |
02/12/2015 |
SOFIA 6F Catheter |
MICROVENTION, INC. |
K110741 |
03/16/2011 |
SCEPTER C OCCLUSION BALLOON CATHETER |
MICROVENTION, INC. |
K120917 |
03/27/2012 |
HEADWAY DUO MICROCATHETER |
MICROVENTION, INC. |
K090891 |
03/30/2009 |
MICROPLEX COIL SYSTEM-COSMOS |
MICROVENTION, INC. |
K150870 |
04/01/2015 |
HydroPearl Microspheres, HydroPearl Microspheres |
MICROVENTION, INC. |
K150958 |
04/09/2015 |
LifePearl Microshperes |
MicroVention, Inc. |
K101542 |
06/03/2010 |
HEADWAY 17 ADVANCED MICROCATHETER |
MICROVENTION, INC. |
K091641 |
06/04/2009 |
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) |
MICROVENTION, INC. |
K091882 |
06/24/2009 |
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM |
MICROVENTION, INC. |
K142014 |
07/24/2014 |
SOFIA DISTAL ACCESS CATHETER |
MICROVENTION, INC. |
K093002 |
09/28/2009 |
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 |
MICROVENTION, INC. |
K173200 |
10/02/2017 |
SOFIA Plus Aspiration Catheter |
MicroVention, Inc. |
K093160 |
10/06/2009 |
HEADWAY 21 MICROCATHETER, MODEL: MC212150S |
MICROVENTION, INC. |
K093397 |
10/30/2009 |
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE |
MICROVENTION, INC. |
K093647 |
11/25/2009 |
TRAXCESS DOCKING WIRE |
MICROVENTION, INC. |
K133725 |
12/06/2013 |
TRAXCESS 14 GUIDEWIRE |
MICROVENTION, INC. |
K161367 |
05/17/2016 |
HydroCoil Embolic System (HES) |
MICROVENTION, INC. |
K161452 |
05/26/2016 |
MicroPlex Coil System (MCS) - HyperSoft 3D |
MICROVENTION, INC. |
K161803 |
06/30/2016 |
Traxcess .007 Mini Guidewire |
MICROVENTION, INC. |
K192135 |
08/07/2019 |
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) |
MicroVention, Inc. |
K153053 |
10/20/2015 |
Traxcess Pro 14 Guidewire |
MICROVENTION, INC. |
K163154 |
11/10/2016 |
Traxcess 7 Mini XSoft Guidewire |
MicroVention, Inc. |
K222115 |
07/18/2022 |
ISAAC Neurovascular Navigation Catheter |
MicroVention, Inc. |
K193607 |
12/26/2019 |
BOBBY Balloon Guide Catheter |
MicroVention, Inc. |
K112181 |
07/28/2011 |
HYDROCOIL(R) EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K020434 |
02/08/2002 |
MICROPLEX COIL SYSTEM (MCS) |
MICROVENTION, INC. |
K070656 |
03/09/2007 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K050954 |
04/15/2005 |
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K041551 |
06/09/2004 |
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K021914 |
06/11/2002 |
MICROPLEX COIL SYSTEMS (MCS) |
MICROVENTION, INC. |
K012145 |
07/10/2001 |
MICROPLEX COIL SYSTEM |
MICROVENTION, INC. |
K071939 |
07/13/2007 |
HYDROCOIL EMBOLIC SYSTEMS (HES) |
MICROVENTION, INC. |
K032590 |
08/22/2003 |
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K033836 |
12/10/2003 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
K022735 |
08/19/2002 |
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT |
MICROVENTION, INC. |
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