FDA 510(k) Applications for Medical Device Product Code "KRD"
(Device, Vascular, For Promoting Embolization )
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220567 | ABK Biomedical Inc | Easi-Vue embolic microspheres System | 09/07/2022 |
| K234123 | ABK Biomedical Inc | Easi-Vue« embolic microspheres System | 02/13/2024 |
| 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 |
| K251383 | Balt USA, LLC | Prestige Coil System (Prestige Packing Line Extension) | 05/30/2025 |
| 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 |
| K250971 | Biosphere Medical, S.A. | Embosphere Microspheres | 05/16/2025 |
| 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 |
| K242507 | Boston Scientific | OBSIDIOÖ Conformable Embolic | 10/03/2024 |
| 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 |
| K250276 | Embolization Inc. | Nitinol Enhanced Device (NED) | 05/15/2025 |
| K123696 | ENDOSHAPE, INC. | MEDUSA VASCULAR PLUG | 10/25/2013 |
| K140796 | ENDOSHAPE, INC. | MEDUSA VASCULAR PLUG, | 12/02/2014 |
| K232934 | Hangzhou Yangshun Medical Technology Co.,Ltd | Sunsphere | 05/30/2024 |
| K093813 | IMBIOTECHNOLOGIES | OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE | 05/10/2010 |
| K240873 | Instylla, Inc. | TEMBO Embolic System | 12/16/2024 |
| K182944 | KA Medical, LLC | Dr. Amplatz Micro Plug | 04/17/2019 |
| K212817 | Merit Medical System, Inc. | Merit Siege Vascular Plug | 12/15/2021 |
| K240261 | Merit Medical Systems, Inc. | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | 05/02/2024 |
| 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 |
| K250133 | Nuvascular Inc. | HARBOR Occlusion Device | 07/09/2025 |
| 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 |
| K250079 | Penumbra, Inc. | Ruby XL System | 03/14/2025 |
| 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 |
| K231554 | Suzhou Haowei Medical Technology Co., Ltd. | UniPearls« Embolic Microspheres | 11/14/2023 |
| 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 |
| K242608 | Varian Medical Systems, Inc. | Embozene Color-Advanced Microspheres | 01/17/2025 |
| K242794 | Varian Medical Systems, Inc. | ONCOZENE Microspheres | 10/16/2024 |
| 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 |
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