ClearanceBrief
Panels › Cardiovascular › Product code KRD · Class 2

Device, Vascular, For Promoting Embolization

Regulation 870.3300

8510(k)s in 12 months (133 all time)
1recalls in 12 months (20 all time)
18recalls that name a 510(k)
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Top companies in KRD

Decided510(k)Device and applicantCode
Sep 6, 2017K172372QuadraSphere Microspheres
Biosphere Medical, S.A., FR
KRD
Aug 18, 2017K171845EMBA Hourglass Peripheral Embolization Device
Emba Medical Limited
KRD
Mar 3, 2017K162524AZUR CX Detachable 18 Peripheral Coil System
MicroVention, Inc.
KRD
Dec 16, 2016K162373LC Bead LUMI
Biocompatibles UK Limited, GB
KRD
Aug 3, 2016K160219Hilal Embolization MicroCoils
Cook Incorporated
KRD
May 19, 2016K153778Nester Embolization Coils, Tornado Embolization Coils
Cook Incorporated
KRD
Mar 7, 2016K150876Bead Block
Biocompatibles UK , Ltd., GB
KRD
Dec 21, 2015K150870HydroPearl Microspheres, HydroPearl Microspheres
MicroVention, Inc.
KRD
Dec 18, 2015K150964MReye Flipper Detachable Embolization Coil and Delivery System
Cook Incorporated
KRD
Dec 18, 2015K150931MReye Embolization Coils
Cook Incorporated
KRD
Dec 11, 2015K152157LC Bead LUMI
Biocompatibles UK , Ltd., GB
KRD
Nov 23, 2015K153102QuadraSphere Microspheres
Biosphere Medical, S.A., FR
KRD
Sep 25, 2015K151358AZUR CX Detachable 35 Coils
MicroVention, Inc.
KRD
Sep 25, 2015K150402Endoluminal Occlusion System-EOS
Artventive Medical Group, Inc.
KRD
Sep 17, 2015K150958LifePearl Microshperes
MicroVention, Inc.
KRD
Jul 27, 2015K151187QuadraSphere Microspheres
Biosphere Medical, S.A., FR
KRD
Jul 22, 2015K151676Retracta Detachable Embolization Coil
Cook Incorporated
KRD
Apr 22, 2015K150108Reverse Medical Micro Vascular Plug System
Reverse Medical Corporation
KRD
Dec 3, 2014K133924ENDOLUMINAL OCCLUSION SYSTEM (EOS)
Artventive Medical Group, Inc.
KRD
Dec 2, 2014K140796MEDUSA VASCULAR PLUG,
Endoshape, Inc.
KRD
Nov 20, 2014K143038Gel-Block 10X embolization pledgets
Vascular Solutions, Inc.
KRD
Oct 8, 2014K141378IDC INTERLOCKING DETACHABLE COIL
Boston Scientific Corporation
KRD
Aug 7, 2014K141209EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES
Celonova Biosciences, Inc.
KRD
Jun 18, 2014K141313REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
Reverse Medical Corporation
KRD
Apr 25, 2014K133237GEL-BEAD EMBOLIZATION SPHERES
Vascular Solutions, Inc.
KRD
Dec 20, 2013K133626AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
MicroVention, Inc.
KRD
Nov 27, 2013K133282REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
Reverse Medical Corporation
KRD
Nov 14, 2013K133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
KRD
Oct 28, 2013K132083AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
MicroVention, Inc.
KRD
Oct 25, 2013K123696MEDUSA VASCULAR PLUG
Endoshape, Inc.
KRD
Oct 3, 2013K132675EMBOZENE MICROSPHERES
Celonova Biosciences, Inc.
KRD
Sep 13, 2013K132578INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
KRD
Jul 2, 2013K123803REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
Reverse Medical Corporation
KRD
Jun 17, 2013K130577AZUR PUSHABLE 18 & 35 SYSTEM
MicroVention, Inc.
KRD
Mar 4, 2013K130307ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
Celonova Biosciences, Inc.
KRD
Jan 3, 2013K123712RETRACTA DETACHABLE EMBOLIZATION COIL
Cook Incorporated
KRD
Nov 28, 2012K123384AZUR CX DETACHABLE 18
MicroVention, Inc.
KRD
Nov 28, 2012K122543AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
MicroVention, Inc.
KRD
Aug 29, 2012K122316AZUR DETACHABLE 35
MicroVention, Inc.
KRD
Jun 12, 2012K113658AMPLATZER VASCULAR PLUG 4
Aga Medical Corp.
KRD
May 14, 2012K113266GEL-BLOCK EMBOLIZATION PLEDGETS
Vascular Solutions, Inc.
KRD
Apr 17, 2012K120816INZONE DETACHMENT SYSTEM
Stryker
KRD
Mar 28, 2012K120630AZUR DETACHABLE 18
MicroVention, Inc.
KRD
Jan 11, 2012K113651INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corporation
KRD
Aug 12, 2011K112103INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
KRD
Jun 15, 2011K111307AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
MicroVention, Inc.
KRD
Mar 3, 2011K110295INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
KRD
Mar 3, 2011K102912INTERLOCK FIBERED IDC OCCLUSION SYSTEM
Boston Scientific
KRD
Feb 11, 2011K102714COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
Boston Scientific Corp
KRD
Nov 18, 2010K102365MICROPLEX COIL SYSTEM- COSMOS
MicroVention, Inc.
KRD

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