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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