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
Cleared
Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
21d
Cleared
Jun 15, 2011
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
MicroVention, Inc.
Cardiovascular
36d
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
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
Aug 19, 2008
AXIUM DETACHABLE COIL SYSTEM
Micro Therapeutics, Inc.
Cardiovascular
84d
Cleared
Jan 11, 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
MicroVention, Inc.
Cardiovascular
182d
Cleared
Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
Cook, Inc.
Cardiovascular
15d
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
Apr 13, 2004
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
Boston Scientific Corp
Cardiovascular
61d
Cleared
Mar 26, 2004
CONTOUR SE MICROSPHERES
Boston Scientific Corp
Cardiovascular
86d
Cleared
Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
Cook, Inc.
Cardiovascular
90d
Cleared
Dec 20, 1999
EMBOLIZATION COIL SYSTEM
Cook, Inc.
Cardiovascular
180d
Cleared
Feb 26, 1997
BERENSTEIN COIL
Target Therapeutics
Cardiovascular
134d
Cleared
Feb 06, 1996
FIBERED PLATINUM COIL, .035 TYPE
Target Therapeutics
Cardiovascular
82d
Cleared
Nov 28, 1994
COIL POSITIONER SET
Cook, Inc.
Cardiovascular
319d
Cleared
Oct 14, 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
Cook, Inc.
Cardiovascular
227d