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., Boston Scientific Corp and Cook, Inc..

132
Total
132
Cleared
121d
Avg days
1985
Since
132 devices
73–96 of 132
Cleared Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103
Boston Scientific Corp
Cardiovascular · 21d
Cleared Jun 15, 2011
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
K111307
MicroVention, Inc.
Cardiovascular · 36d
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 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 Aug 19, 2008
AXIUM DETACHABLE COIL SYSTEM
K081465
Micro Therapeutics, Inc.
Cardiovascular · 84d
Cleared Jan 11, 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939
MicroVention, Inc.
Cardiovascular · 182d
Cleared Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619
Cook, Inc.
Cardiovascular · 15d
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 Apr 13, 2004
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
K040342
Boston Scientific Corp
Cardiovascular · 61d
Cleared Mar 26, 2004
CONTOUR SE MICROSPHERES
K034068
Boston Scientific Corp
Cardiovascular · 86d
Cleared Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455
Cook, Inc.
Cardiovascular · 90d
Cleared Dec 20, 1999
EMBOLIZATION COIL SYSTEM
K992121
Cook, Inc.
Cardiovascular · 180d
Cleared Feb 26, 1997
BERENSTEIN COIL
K964112
Target Therapeutics
Cardiovascular · 134d
Cleared Feb 06, 1996
FIBERED PLATINUM COIL, .035 TYPE
K955293
Target Therapeutics
Cardiovascular · 82d
Cleared Nov 28, 1994
COIL POSITIONER SET
K940189
Cook, Inc.
Cardiovascular · 319d
Cleared Oct 14, 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
K940982
Cook, Inc.
Cardiovascular · 227d