KRD · Class II · 21 CFR 870.3300

FDA Product Code KRD: Device, Vascular, For Promoting Embolization

Under FDA product code KRD, vascular embolization devices are cleared for the occlusion of blood vessels in therapeutic endovascular procedures.

These devices — including coils, plugs, and liquid embolic agents — are delivered through catheters to deliberately occlude target vessels, reducing blood flow to tumors, aneurysms, or arteriovenous malformations. Embolization is a cornerstone of interventional radiology and neurovascular surgery.

KRD devices are Class II medical devices, regulated under 21 CFR 870.3300 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include MicroVention, Inc., Biosphere Medical, S.A. and Boston Scientific Corp.

133
Total
133
Cleared
121d
Avg days
1985
Since
133 devices
97–120 of 133
Cleared Mar 03, 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
K102912
Boston Scientific
Cardiovascular · 153d
Cleared Mar 03, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K110295
Boston Scientific Corp
Cardiovascular · 30d
Cleared Feb 11, 2011
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
K102714
Boston Scientific Corp
Cardiovascular · 144d
Cleared Nov 18, 2010
MICROPLEX COIL SYSTEM- COSMOS
K102365
MicroVention, Inc.
Neurology · 90d
Cleared Sep 10, 2010
ACTA VESSEL OCCLUSION SYSTEM (VOS)
K091952
Nfocus Neuromedical, Inc.
Cardiovascular · 436d
Cleared May 10, 2010
OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
K093813
Imbiotechnologies
Cardiovascular · 150d
Cleared Oct 28, 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
K093002
MicroVention, Inc.
Cardiovascular · 30d
Cleared Jul 08, 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
K091882
MicroVention, Inc.
Cardiovascular · 14d
Cleared Apr 02, 2009
COOK MREYE EMBOLIZATION COILS
K090624
Cook, Inc.
Cardiovascular · 24d
Cleared Feb 27, 2009
CONCERTO DETACHABLE COIL SYSTEM
K090046
Micro Therapeutics, Inc.
Cardiovascular · 51d
Cleared Dec 24, 2008
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
K083091
Biocompatibles UK Limited
Cardiovascular · 68d
Cleared Dec 15, 2008
EMBOZENE MICROSPHERES
K073417
Celonova Biosciences, Inc.
Cardiovascular · 377d
Cleared Aug 19, 2008
AXIUM DETACHABLE COIL SYSTEM
K081465
Micro Therapeutics, Inc.
Cardiovascular · 84d
Cleared Mar 05, 2008
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES
K073544
Rj Medical, Inc.
Cardiovascular · 78d
Cleared Jan 11, 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939
MicroVention, Inc.
Cardiovascular · 182d
Cleared Aug 15, 2007
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
K071699
Aga Medical Corp.
Cardiovascular · 55d
Cleared Jun 18, 2007
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
K071125
Aga Medical Corp.
Cardiovascular · 56d
Cleared Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619
Cook, Inc.
Cardiovascular · 15d
Cleared Nov 07, 2006
HEPASPHERE MICROSPHERES
K052742
Biosphere Medical, Inc.
Neurology · 403d
Cleared Sep 19, 2006
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K061790
Protein Polymer Technologies, Inc.
Neurology · 85d
Cleared Jan 31, 2006
FIBERED IDC OCCLUSION SYSTEM
K060078
Boston Scientific Corporation
Cardiovascular · 21d
Cleared Nov 23, 2005
MREYE EMBOLIZATION COIL
K052834
Cook, Inc.
Cardiovascular · 48d
Cleared May 06, 2005
CONCENTRIC EMBOLIC PEARLS
K050470
Concentric Medical, Inc.
Cardiovascular · 72d
Cleared Feb 03, 2005
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
K043371
Biomerix Corporation
Cardiovascular · 57d