FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K220567 |
ABK Biomedical Inc |
Easi-Vue embolic microspheres System |
09/07/2022 |
K031810 |
AGA MEDICAL CORP. |
AMPLATZER VASCULAR PLUG |
09/09/2003 |
K113658 |
AGA MEDICAL CORP. |
AMPLATZER VASCULAR PLUG 4 |
06/12/2012 |
K071125 |
AGA MEDICAL CORP. |
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 |
06/18/2007 |
K071699 |
AGA MEDICAL CORP. |
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 |
08/15/2007 |
K213200 |
Artio Medical, Inc. |
Solus Gold Embolization Device |
03/21/2022 |
K133924 |
ARTVENTIVE MEDICAL GROUP, INC |
ENDOLUMINAL OCCLUSION SYSTEM (EOS) |
12/03/2014 |
K150402 |
ARTVENTIVE MEDICAL GROUP, INC |
Endoluminal Occlusion System-EOS |
09/25/2015 |
K212057 |
ArtVentive Medical Group, Inc. |
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS |
03/01/2022 |
K220699 |
Bait USA, LLC |
Prestige Coil System |
04/08/2022 |
K083091 |
BIOCOMPATIBLES U.K. LIMITED |
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES |
12/24/2008 |
K162373 |
Biocompatibles UK Limited |
LC Bead LUMI |
12/16/2016 |
K150876 |
BIOCOMPATIBLES UK LTD |
Bead Block |
03/07/2016 |
K152157 |
BIOCOMPATIBLES UK LTD |
LC Bead LUMI |
12/11/2015 |
K043371 |
BIOMERIX CORPORATION |
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER |
02/03/2005 |
K151187 |
BIOSPHERE MEDICAL S.A. |
QuadraSphere Microspheres |
07/27/2015 |
K052742 |
BIOSPHERE MEDICAL, INC. |
HEPASPHERE MICROSPHERES |
11/07/2006 |
K181021 |
Biosphere Medical, S.A. |
EmboCube Embolization Gelatin |
09/27/2018 |
K183120 |
Biosphere Medical, S.A. |
EmboCube Embolization Gelatin |
08/06/2019 |
K181300 |
Biosphere Medical, S.A. |
Embosphere Microspheres |
07/16/2018 |
K172372 |
Biosphere Medical, S.A. |
QuadraSphere Microspheres |
09/06/2017 |
K153102 |
BIOSPHERE MEDICAL, S.A. |
QuadraSphere Microspheres |
11/23/2015 |
K183578 |
Biosphere Medical, S.A. |
Torpedo Gelatin Foam |
06/18/2019 |
K192480 |
Biosphere Medical, S.A. |
Torpedo Gelatin Foam |
11/21/2019 |
K102714 |
BOSTON SCIENTIFIC CORP. |
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL |
02/11/2011 |
K034068 |
BOSTON SCIENTIFIC CORP. |
CONTOUR SE MICROSPHERES |
03/26/2004 |
K132578 |
BOSTON SCIENTIFIC CORP. |
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM |
09/13/2013 |
K112103 |
BOSTON SCIENTIFIC CORP. |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
08/12/2011 |
K110295 |
BOSTON SCIENTIFIC CORP. |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
03/03/2011 |
K133208 |
BOSTON SCIENTIFIC CORP. |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
11/14/2013 |
K040342 |
BOSTON SCIENTIFIC CORP. |
INTERLOCKING DETACHABLE COIL SYSTEM (IDC) |
04/13/2004 |
K213398 |
Boston Scientific Corporation |
EMBOLD Fibered Detachable Coil System |
04/12/2022 |
K230706 |
Boston Scientific Corporation |
EMBOLDÖ Soft Detachable Coil System |
06/27/2023 |
K060078 |
Boston Scientific Corporation |
FIBERED IDC OCCLUSION SYSTEM |
01/31/2006 |
K141378 |
Boston Scientific Corporation |
IDC INTERLOCKING DETACHABLE COIL |
10/08/2014 |
K113651 |
Boston Scientific Corporation |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
01/11/2012 |
K102912 |
BOSTONSCIENTIFIC |
INTERLOCK FIBERED IDC OCCLUSION SYSTEM |
03/03/2011 |
K191532 |
C. R. Bard, Inc. |
The Caterpillar and Caterpillar Micro Arterial Embolization Devices |
02/04/2020 |
K073417 |
CELONOVA BIOSCIENCES, INC. |
EMBOZENE MICROSPHERES |
12/15/2008 |
K130307 |
CELONOVA BIOSCIENCES, INC. |
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE |
03/04/2013 |
K141209 |
CELONOVA BIOSCIENCES, INC. |
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES |
08/07/2014 |
K132675 |
CELONOVA BIOSCIENCES, INC. |
EMBOZENE MICROSPHERES |
10/03/2013 |
K050470 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC EMBOLIC PEARLS |
05/06/2005 |
K160219 |
Cook Incorporated |
Hilal Embolization MicroCoils |
08/03/2016 |
K150931 |
Cook Incorporated |
MReye Embolization Coils |
12/18/2015 |
K150964 |
Cook Incorporated |
MReye Flipper Detachable Embolization Coil and Delivery System |
12/18/2015 |
K153778 |
COOK INCORPORATED |
Nester Embolization Coils, Tornado Embolization Coils |
05/19/2016 |
K123712 |
COOK INCORPORATED |
RETRACTA DETACHABLE EMBOLIZATION COIL |
01/03/2013 |
K151676 |
COOK INCORPORATED |
Retracta Detachable Embolization Coil |
07/22/2015 |
K090624 |
COOK, INC. |
COOK MREYE EMBOLIZATION COILS |
04/02/2009 |
K992121 |
COOK, INC. |
EMBOLIZATION COIL SYSTEM |
12/20/1999 |
K993455 |
COOK, INC. |
FLIPPER DETACHABLE EMBOLIZATION COIL |
01/11/2000 |
K063619 |
COOK, INC. |
FLIPPER DETACHABLE EMBOLIZATION COILS |
12/20/2006 |
K052834 |
COOK, INC. |
MREYE EMBOLIZATION COIL |
11/23/2005 |
K171845 |
EMBA Medical Limited |
EMBA Hourglass Peripheral Embolization Device |
08/18/2017 |
K200083 |
Embolic Acceleration, LLC |
EMBA Hourglass Peripheral Embolization Device (PED) |
02/14/2020 |
K123696 |
ENDOSHAPE, INC. |
MEDUSA VASCULAR PLUG |
10/25/2013 |
K140796 |
ENDOSHAPE, INC. |
MEDUSA VASCULAR PLUG, |
12/02/2014 |
K093813 |
IMBIOTECHNOLOGIES |
OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE |
05/10/2010 |
K182944 |
KA Medical, LLC |
Dr. Amplatz Micro Plug |
04/17/2019 |
K212817 |
Merit Medical System, Inc. |
Merit Siege Vascular Plug |
12/15/2021 |
K081465 |
MICRO THERAPEUTICS, INC. |
AXIUM DETACHABLE COIL SYSTEM |
08/19/2008 |
K090046 |
MICRO THERAPEUTICS, INC. |
CONCERTO DETACHABLE COIL SYSTEM |
02/27/2009 |
K202850 |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Concerto Versa, Detachable Coil |
02/09/2021 |
K151358 |
Micro Vention, Inc. |
AZUR CX Detachable 35 Coils |
09/25/2015 |
K120630 |
MICRO VENTION, INC. |
AZUR DETACHABLE 18 |
03/28/2012 |
K132083 |
MICRO VENTION, INC. |
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 |
10/28/2013 |
K223050 |
MicroVention Inc. |
AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) |
12/21/2022 |
K191680 |
MicroVention Inc. |
AZUR Vascular Plug |
03/20/2020 |
K162524 |
MicroVention, Inc |
AZUR CX Detachable 18 Peripheral Coil System |
03/03/2017 |
K123384 |
MICROVENTION, INC. |
AZUR CX DETACHABLE 18 |
11/28/2012 |
K122316 |
MICROVENTION, INC. |
AZUR DETACHABLE 35 |
08/29/2012 |
K111307 |
MICROVENTION, INC. |
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM |
06/15/2011 |
K091882 |
MICROVENTION, INC. |
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM |
07/08/2009 |
K093002 |
MICROVENTION, INC. |
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 |
10/28/2009 |
K122543 |
MICROVENTION, INC. |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
11/28/2012 |
K133626 |
MICROVENTION, INC. |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
12/20/2013 |
K130577 |
MICROVENTION, INC. |
AZUR PUSHABLE 18 & 35 SYSTEM |
06/17/2013 |
K071939 |
MICROVENTION, INC. |
HYDROCOIL EMBOLIC SYSTEMS (HES) |
01/11/2008 |
K150870 |
MICROVENTION, INC. |
HydroPearl Microspheres, HydroPearl Microspheres |
12/21/2015 |
K150958 |
MicroVention, Inc. |
LifePearl Microshperes |
09/17/2015 |
K102365 |
MICROVENTION, INC. |
MICROPLEX COIL SYSTEM- COSMOS |
11/18/2010 |
K091952 |
NFOCUS NEUROMEDICAL, INC. |
ACTA VESSEL OCCLUSION SYSTEM (VOS) |
09/10/2010 |
K213385 |
Obsidio, Inc. |
GEM |
07/01/2022 |
K203025 |
Okami Medical |
LOBO Vascular Occlusion System (model LOBO-5) |
11/05/2020 |
K220383 |
Okami Medical |
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) |
04/29/2022 |
K192083 |
Okami Medical |
Okami Medical LOBO Vascular Occlusion System |
10/30/2019 |
K061790 |
PROTEIN POLYMER TECHNOLOGIES, INC. |
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES |
09/19/2006 |
K133282 |
REVERSE MEDICAL CORPORATION |
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM |
11/27/2013 |
K123803 |
REVERSE MEDICAL CORPORATION |
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM |
07/02/2013 |
K141313 |
REVERSE MEDICAL CORPORATION |
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM |
06/18/2014 |
K150108 |
REVERSE MEDICAL CORPORATION |
Reverse Medical Micro Vascular Plug System |
04/22/2015 |
K073544 |
RJ MEDICAL, INC. |
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES |
03/05/2008 |
K181051 |
Shape Memory Medical |
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm |
06/22/2018 |
K182390 |
Shape Memory Medical |
IMPEDE-FX Embolization Plug |
05/23/2019 |
K120816 |
Stryker |
INZONE DETACHMENT SYSTEM |
04/17/2012 |
K210562 |
Suzhou Hengrui Hongyuan Medical Co., Ltd. |
HRSpheres Narrow-Size Embolic Microspheres |
10/01/2021 |
K964112 |
TARGET THERAPEUTICS |
BERENSTEIN COIL |
02/26/1997 |
K955293 |
TARGET THERAPEUTICS |
FIBERED PLATINUM COIL, .035 TYPE |
02/06/1996 |
K171946 |
Vascular Solutions, Inc. |
Gel-Bead |
10/25/2017 |
K173891 |
Vascular Solutions, Inc. |
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume |
01/19/2018 |
K133237 |
VASCULAR SOLUTIONS, INC. |
GEL-BEAD EMBOLIZATION SPHERES |
04/25/2014 |
K143038 |
VASCULAR SOLUTIONS, INC. |
Gel-Block 10X embolization pledgets |
11/20/2014 |
K113266 |
VASCULAR SOLUTIONS, INC. |
GEL-BLOCK EMBOLIZATION PLEDGETS |
05/14/2012 |