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
Cleared
Mar 03, 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
Boston Scientific
Cardiovascular
153d
Cleared
Mar 03, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
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
Boston Scientific Corp
Cardiovascular
144d
Cleared
Nov 18, 2010
MICROPLEX COIL SYSTEM- COSMOS
MicroVention, Inc.
Neurology
90d
Cleared
Sep 10, 2010
ACTA VESSEL OCCLUSION SYSTEM (VOS)
Nfocus Neuromedical, Inc.
Cardiovascular
436d
Cleared
May 10, 2010
OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
Imbiotechnologies
Cardiovascular
150d
Cleared
Oct 28, 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
MicroVention, Inc.
Cardiovascular
30d
Cleared
Jul 08, 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
MicroVention, Inc.
Cardiovascular
14d
Cleared
Apr 02, 2009
COOK MREYE EMBOLIZATION COILS
Cook, Inc.
Cardiovascular
24d
Cleared
Feb 27, 2009
CONCERTO DETACHABLE COIL SYSTEM
Micro Therapeutics, Inc.
Cardiovascular
51d
Cleared
Dec 24, 2008
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
Biocompatibles UK Limited
Cardiovascular
68d
Cleared
Dec 15, 2008
EMBOZENE MICROSPHERES
Celonova Biosciences, Inc.
Cardiovascular
377d
Cleared
Aug 19, 2008
AXIUM DETACHABLE COIL SYSTEM
Micro Therapeutics, Inc.
Cardiovascular
84d
Cleared
Mar 05, 2008
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES
Rj Medical, Inc.
Cardiovascular
78d
Cleared
Jan 11, 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
MicroVention, Inc.
Cardiovascular
182d
Cleared
Aug 15, 2007
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
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
Aga Medical Corp.
Cardiovascular
56d
Cleared
Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
Cook, Inc.
Cardiovascular
15d
Cleared
Nov 07, 2006
HEPASPHERE MICROSPHERES
Biosphere Medical, Inc.
Neurology
403d
Cleared
Sep 19, 2006
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
Protein Polymer Technologies, Inc.
Neurology
85d
Cleared
Jan 31, 2006
FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corporation
Cardiovascular
21d
Cleared
Nov 23, 2005
MREYE EMBOLIZATION COIL
Cook, Inc.
Cardiovascular
48d
Cleared
May 06, 2005
CONCENTRIC EMBOLIC PEARLS
Concentric Medical, Inc.
Cardiovascular
72d
Cleared
Feb 03, 2005
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
Biomerix Corporation
Cardiovascular
57d