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 10, 2010K091952ACTA VESSEL OCCLUSION SYSTEM (VOS)
Nfocus Neuromedical, Inc.
KRD
May 10, 2010K093813OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
Imbiotechnologies
KRD
Oct 28, 2009K093002AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
MicroVention, Inc.
KRD
Jul 8, 2009K091882AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
MicroVention, Inc.
KRD
Apr 2, 2009K090624COOK MREYE EMBOLIZATION COILS
Cook, Inc.
KRD
Feb 27, 2009K090046CONCERTO DETACHABLE COIL SYSTEM
Micro Therapeutics, Inc.
KRD
Dec 24, 2008K083091LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
Biocompatibles UK Limited
KRD
Dec 15, 2008K073417EMBOZENE MICROSPHERES
Celonova Biosciences, Inc.
KRD
Aug 19, 2008K081465AXIUM DETACHABLE COIL SYSTEM
Micro Therapeutics, Inc.
KRD
Mar 5, 2008K073544PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES
Rj Medical, Inc.
KRD
Jan 11, 2008K071939HYDROCOIL EMBOLIC SYSTEMS (HES)
MicroVention, Inc.
KRD
Aug 15, 2007K071699AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
Aga Medical Corp.
KRD
Jun 18, 2007K071125AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
Aga Medical Corp.
KRD
Dec 20, 2006K063619FLIPPER DETACHABLE EMBOLIZATION COILS
Cook, Inc.
KRD
Nov 7, 2006K052742HEPASPHERE MICROSPHERES
Biosphere Medical, Inc.
KRD
Sep 19, 2006K061790PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
Protein Polymer Technologies, Inc.
KRD
Jan 31, 2006K060078FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corporation
KRD
Nov 23, 2005K052834MREYE EMBOLIZATION COIL
Cook, Inc.
KRD
May 6, 2005K050470CONCENTRIC EMBOLIC PEARLS
Concentric Medical, Inc.
KRD
Feb 3, 2005K043371BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
Biomerix Corporation
KRD
Apr 13, 2004K040342INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
Boston Scientific Corp
KRD
Mar 26, 2004K034068CONTOUR SE MICROSPHERES
Boston Scientific Corp
KRD
Sep 9, 2003K031810AMPLATZER VASCULAR PLUG
Aga Medical Corp.
KRD
Jan 11, 2000K993455FLIPPER DETACHABLE EMBOLIZATION COIL
Cook, Inc.
KRD
Dec 20, 1999K992121EMBOLIZATION COIL SYSTEM
Cook, Inc.
KRD
Feb 26, 1997K964112BERENSTEIN COIL
Target Therapeutics
KRD
Feb 6, 1996K955293FIBERED PLATINUM COIL, .035 TYPE
Target Therapeutics
KRD
Nov 28, 1994K940189COIL POSITIONER SET
Cook, Inc.
KRD
Oct 14, 1994K940982ARTERIAL EMBOLIZATION DEVICE (KRD)
Cook, Inc.
KRD
Apr 20, 1992K914786TARGET THERAPEUTICS COILS
Target Therapeutics
KRD
Jul 14, 1989K892446SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02
Shiley, Inc.
KRD
Aug 11, 1988K882136INTERSEPT* OXYGEN GAS LINE FILTER
Medtronic Blood Systems, Inc.
KRD
Nov 22, 1985K854273SILICONE OIL 350 CNETISTOKE
Pacific Medical Industries
KRD

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