FDA 510(k) Applications for Medical Device Product Code "HCG"
(Device, Neurovascular Embolization)

FDA 510(k) Number Applicant Device Name Decision Date
K042297 ACTA VASCULAR SYSTEMS, INC. ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES 06/01/2005
K964021 BAXTER EDWARDS INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) 03/27/1997
K033761 BIOCOMPATIBLES U.K. LIMITED GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES 02/04/2004
K042231 BIOCOMPATIBLES U.K. LIMITED GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES 11/12/2004
K094018 BIOCOMPATIBLES U.K. LIMITED LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES 04/16/2010
K023089 BIOCURE, INC. GELSPHERES EMBOLIC AGENT 12/16/2002
K991549 BIOSPHERE MEDICAL EMBOSPHERE MICROSPHERES 04/26/2000
K010026 BIOSPHERE MEDICAL, INC. EMBOGOLD MICROSPHERE 06/21/2001
K113822 BIOSPHERE MEDICAL, INC. QUADRASPHERE 30 TO 60 03/08/2012
K131475 BLOCKADE MEDICAL BARRICADE EMBOLIZATION COIL SYSTEM 07/25/2013
K151760 BLOCKADE MEDICAL Barricade Embolization Coil System 07/27/2015
K132482 BLOCKADE MEDICAL BARRICADE EMBOLIZATION COIL SYSTEM 10/10/2013
K140104 BLOCKADE MEDICAL BARRICADE EMBOLIZATION COIL SYSTEM 02/13/2014
K142513 BLOCKADE MEDICAL Barricade Embolization Coil System 11/13/2014
K123338 BLOCKADE MEDICAL BARRICADE EMBOLIZATION COIL SYSTEM 03/28/2013
K172390 Blockade Medical, LLC (d.b.a. Balt USA) Optima Coil System 02/18/2018
K022427 BOSTON SCIENTIFIC CORP. CONTOUR SE MICROSPHERES 08/22/2002
K032707 BOSTON SCIENTIFIC CORP. CONTOUR SE MICROSPHERES (SYRINGE) 09/23/2003
K103355 BOSTON SCIENTIFIC CORP. GDC 360 DETEACHABLE COIL 02/16/2011
K042539 BOSTON SCIENTIFIC CORP. GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL 10/19/2004
K103008 BOSTON SCIENTIFIC CORP. INZONE DETACHMENT SYSTEM 12/10/2010
K092666 BOSTON SCIENTIFIC CORP. INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 09/30/2009
K050700 BOSTON SCIENTIFIC CORP. MATRIX STRETCH RESISTANT (SR) COILS 04/15/2005
K032542 BOSTON SCIENTIFIC CORP. MODIFICATION TO CONTOUR SE MICROSPHERES 09/16/2003
K071634 BOSTON SCIENTIFIC CORP. MODIFICATION TO:CONTOUR SE MICROSPHERES 07/12/2007
K102672 BOSTON SCIENTIFIC CORP. TARGET DETACHABLE COIL 10/15/2010
K093142 BOSTON SCIENTIFIC CORP. TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM 02/04/2010
K993418 BOSTON SCIENTIFIC, TARGET FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL 01/21/2000
K021494 BOSTON SCIENTIFIC, TARGET GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 06/06/2002
K030475 BOSTON SCIENTIFIC, TARGET GDC STRETCH RESISTANT DETACHABLE COIL 03/14/2003
K002181 BOSTON SCIENTIFIC, TARGET GDC ULTRASOFT COIL 08/11/2000
K993417 BOSTON SCIENTIFIC, TARGET GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) 01/21/2000
K993415 BOSTON SCIENTIFIC, TARGET GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 01/21/2000
K991139 BOSTON SCIENTIFIC, TARGET GUGLIELMI DETACHABLE (GDC) 12/22/1999
K031049 BOSTON SCIENTIFIC, TARGET GUGLIELMI DETACHABLE COIL (GDC) 08/01/2003
K001083 BOSTON SCIENTIFIC, TARGET GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 05/03/2000
K012985 BOSTON SCIENTIFIC, TARGET MATRIX DETACHABLE COILS 01/31/2002
K031168 BOSTON SCIENTIFIC, TARGET MATRIX STRETCH RESISTANT DETACHABLE COIL 05/14/2003
K142429 Codman & Shurtleff, Inc CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable 12/24/2014
K171862 Codman & Shurtleff, Inc GALAXY G3 Mini Microcoil Delivery System 09/25/2017
K171747 Codman & Shurtleff, Inc. MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and 07/14/2017
K150319 CODMAN & SHURTLEFF, INC. MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS 06/12/2015
K120686 Codman & Shurtleff, Inc. ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM 04/04/2012
K093973 Codman & Shurtleff, Inc. TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM 05/26/2010
K123560 Codman & Shurtleff, Inc. VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM 01/25/2013
K120274 CODMAN AND SHURTLEFF, INC. DELTAMAXX 18 MICROCOIL SYSTEM 03/02/2012
K000651 COOK, INC. DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM 11/24/2000
K901337 COOK, INC. HILAL EMBOLIZATION MICROCOIL(TM) 11/13/1990
K014041 CORDIS NEUROVASCULAR TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM 03/07/2002
K972881 CORDIS NEUROVASCULAR, INC. CES VASCULAR OCCLUSION SYSTEM 06/04/1998
K964367 CORDIS NEUROVASCULAR, INC. CES VASCULAR OCCLUSION SYSTEM 01/30/1997
K063254 CORDIS NEUROVASCULAR, INC. THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM 12/07/2006
K951314 CORDIS NEUROVASCULAR, INC. TRUEFILL PVA PARTICLES 08/08/1995
K080967 CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT 05/02/2008
K030963 CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM 06/20/2003
K032553 CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM 09/23/2003
K053197 CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION 12/15/2005
K082324 CORDIS NEUROVASCULAR, INC. TRUFILL DCS SYRINGE 09/12/2008
K965174 CORDIS NEUROVASCULAR, INC. TRUFILL PVA PARTICLES 03/21/1997
K983483 CORDIS NEUROVASCULAR, INC. VASCULAR OCCLUSION SYSTEM 03/24/1999
K071962 CORDIS NEUROVASCULAR, INC. VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) 09/26/2007
K944354 INTERVENTIONAL THERAPEUTICS CORP. CONTOUR EMBOLI 12/13/1994
K900723 INTERVENTIONAL THERAPEUTICS CORP. ITC BUNJI COIL 02/19/1991
K920324 INTERVENTIONAL THERAPEUTICS CORP. ITC BUNJI COIL (MODIFICATION) 07/29/1992
K925523 INTERVENTIONAL THERAPEUTICS CORP. ITC BUNJI PLATINUM EMBOLIZATION COIL 03/23/1993
K925876 INTERVENTIONAL THERAPEUTICS CORP. ITC BUNJI PLATINUM EMBOLIZATION COIL 04/15/1993
K914866 INTERVENTIONAL THERAPEUTICS CORP. ITC CONTOUR EMBOLI, MODIFICATION 11/09/1993
K871047 INTERVENTIONAL THERAPEUTICS CORP. RADIOPAQUE SPHERICAL EMBOLI (RSE) 05/22/1987
K913556 IVALON IVALON EMBOLIZATION PARTICLES 04/13/1994
K060747 MICRO THERAPEUTICS, INC. FX DETACHABLE COIL SYSTEM 04/24/2007
K040694 MICRO THERAPEUTICS, INC. MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) 03/25/2004
K050543 MICRO THERAPEUTICS, INC. NEXUS DETACHABLE COIL SYSTEM 04/27/2005
K051425 MICRO THERAPEUTICS, INC. NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR 06/22/2005
K060625 MICRO THERAPEUTICS, INC. NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR 04/20/2006
K051560 MICRO THERAPEUTICS, INC. NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR 06/28/2005
K030392 MICRO THERAPEUTICS, INC. SAPPHIRE DETACHABLE COIL SYSTEM 07/21/2003
K031852 MICRO THERAPEUTICS, INC. SAPPHIRE DETACHABLE FIBER COILS 08/20/2003
K033372 MICRO THERAPEUTICS, INC. SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS 01/09/2004
K041649 MICRO THERAPEUTICS, INC. SAPPHIRE NXT DETACHABLE COIL SYSTEM 07/16/2004
K032497 MICRO THERAPEUTICS, INC. SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT 09/25/2003
K151447 MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR Axium Detachable Coil System 07/28/2015
K133310 MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR AXIUM DETACHABLE COIL SYSTEM 01/10/2014
K162704 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Axium Prime Detachable Coil System 01/03/2017
K162999 MICROVENTION, INC V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System 03/29/2017
K090168 MICROVENTION, INC. AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 03/12/2009
K082461 MICROVENTION, INC. BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B 10/02/2008
K112226 MICROVENTION, INC. HYDROCOIL EMBOLIC SYSTEM (HES) 09/29/2011
K113457 MICROVENTION, INC. HYDROCOIL EMBOLIC SYSTEM (HES) 12/16/2011
K120908 MICROVENTION, INC. HYDROCOIL EMBOLIC SYSTEM (HES) 04/25/2012
K161367 MICROVENTION, INC. HydroCoil Embolic System (HES) 08/31/2016
K070656 MICROVENTION, INC. HYDROCOIL EMBOLIC SYSTEM (HES) 06/15/2007
K033836 MICROVENTION, INC. HYDROCOIL EMBOLIC SYSTEM (HES) 12/30/2003
K091641 MICROVENTION, INC. HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) 06/30/2009
K100454 MICROVENTION, INC. HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V 04/22/2010
K112181 MICROVENTION, INC. HYDROCOIL(R) EMBOLIC SYSTEM (HES) 12/01/2011
K090357 MICROVENTION, INC. HYDROFRAME (HES) 04/10/2009
K080666 MICROVENTION, INC. HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS 07/11/2008
K012145 MICROVENTION, INC. MICROPLEX COIL SYSTEM 10/29/2001
K131948 MICROVENTION, INC. MICROPLEX COIL SYSTEM (MCS) 10/04/2013
K020434 MICROVENTION, INC. MICROPLEX COIL SYSTEM (MCS) 07/29/2002
K161452 MICROVENTION, INC. MicroPlex Coil System (MCS) - HyperSoft 3D 08/31/2016
K050954 MICROVENTION, INC. MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) 06/28/2005
K022735 MICROVENTION, INC. MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT 09/06/2002
K132952 MICROVENTION, INC. MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) 12/19/2013
K153594 MICROVENTION, INC. MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) 01/22/2016
K032590 MICROVENTION, INC. MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) 10/22/2003
K132317 MICROVENTION, INC. MICROPLEX COIL SYSTEM (MCS), VFC 09/20/2013
K103758 MICROVENTION, INC. MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 04/28/2011
K090891 MICROVENTION, INC. MICROPLEX COIL SYSTEM-COSMOS 06/22/2009
K093919 MICROVENTION, INC. MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V 01/21/2010
K093358 MICROVENTION, INC. MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V 01/15/2010
K111451 MICROVENTION, INC. MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX 09/20/2011
K021914 MICROVENTION, INC. MICROPLEX COIL SYSTEMS (MCS) 07/09/2002
K041551 MICROVENTION, INC. MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) 07/07/2004
K090001 MICROVENTION, INC. V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 03/05/2009
K002056 MICRUS CORP. MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 01/11/2001
K032872 MICRUS CORP. MICRUS MICROCOIL SYSTEM 11/28/2003
K031578 MICRUS CORP. MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR 08/01/2003
K033813 MICRUS CORP. MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE 02/04/2004
K022420 MICRUS CORP. MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 10/22/2002
K082739 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL DELIVERY SYSTEM 10/17/2008
K071246 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR 06/01/2007
K070707 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL SYSTEM 04/06/2007
K072173 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC 10/05/2007
K062036 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 08/25/2006
K063653 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC 01/17/2007
K080437 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF 05/08/2008
K080379 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT 06/30/2008
K073442 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOIL SYSTEMS 02/26/2008
K083646 MICRUS ENDOVASCULAR CORPORATION MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL 01/02/2009
K053160 MICRUS ENDOVASCULAR CORPORATION MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE 12/07/2005
K173614 Penumbra, Inc. Penumbra Coil 400, Ruby Coil System, POD System 04/17/2018
K120330 PENUMBRA, INC. PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 04/02/2012
K103305 PENUMBRA, INC. PENUMBRA EMBOLIZATION COIL SYSTEM 01/26/2011
K143218 Penumbra, Inc. Penumbra Smart Coil 03/18/2015
K151572 PENUMBRA, INC. Penumbra Smart Coil 07/10/2015
K160832 PENUMBRA, INC. Penumbra Smart Coil 04/20/2016
K170852 Penumbra, Inc. POD Packing Coil 07/19/2017
K141134 PENUMBRA, INC. POD SYSTEM 07/03/2014
K053548 PROTEIN POLYMER TECHNOLOGIES, INC. MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES 01/30/2006
K073419 RJ MEDICAL, INC. PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES 02/14/2008
K052509 SCION CARDIO-VASCULAR, INC. M-BOLUS EMBOLIC MICROSPHERES 12/11/2006
K160096 STRYKER NEUROVASCULAR InZone Detachment System 02/19/2016
K120850 STRYKER NEUROVASCULAR TARGET DETACHABLE COIL 04/17/2012
K123377 STRYKER NEUROVASCULAR TARGET DETACHABLE COIL 11/30/2012
K113412 STRYKER NEUROVASCULAR TARGET DETACHABLE COIL 12/13/2011
K153658 Stryker Neurovascular Target Detachable Coils 05/19/2016
K161429 Stryker Neurovascular Target Detachable Coils 06/22/2016
K112385 STRYKER NEUROVASCULAR TRAGET DETACHABLE COIL 09/15/2011
K020033 SURGICA CORP. MAXISTAT PVA FOAM EMBOLIZATION PARTICLES 05/31/2002
K032619 SURGICA CORP. MICROSTAT PVA FOAM EMBOLIZATION PARTICLES 02/13/2004
K001678 SURGICA CORP. PVA FOAM EMBOLIZATION PARTICLES 01/25/2001
K961923 TARGET THERAPEUTICS BERENSTEIN COIL 08/15/1996
K891688 TARGET THERAPEUTICS COIL AND COIL DELIVERY SYSTEM 09/22/1989
K951256 TARGET THERAPEUTICS DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 09/08/1995
K963307 TARGET THERAPEUTICS GDC PATIENT RETURN ELECTTRODE MODEL 45021 12/17/1996
K962503 TARGET THERAPEUTICS GUGLIELMI DETACHABLE COIL 09/20/1996
K960705 TARGET THERAPEUTICS GUGLIELMI DETACHABLE COIL 05/21/1996
K911779 TARGET THERAPEUTICS HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED 11/08/1991
K913312 TARGET THERAPEUTICS HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED 11/08/1991
K901721 TARGET THERAPEUTICS MODIFIED TARGET THERAPEUTICS COILS 07/03/1990
K173711 Wallaby Medical, Inc. Wallaby Avenir Coil System 05/04/2018


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