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.
132
Total
132
Cleared
121d
Avg days
1985
Since
132 devices
Cleared
Jun 18, 2014
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
Reverse Medical Corporation
Cardiovascular
29d
Cleared
Apr 25, 2014
GEL-BEAD EMBOLIZATION SPHERES
Vascular Solutions, Inc.
Cardiovascular
186d
Cleared
Dec 20, 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
MicroVention, Inc.
Cardiovascular
24d
Cleared
Nov 27, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
Reverse Medical Corporation
Cardiovascular
33d
Cleared
Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
27d
Cleared
Oct 28, 2013
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
MicroVention, Inc.
Cardiovascular
115d
Cleared
Oct 25, 2013
MEDUSA VASCULAR PLUG
Endoshape, Inc.
Cardiovascular
326d
Cleared
Oct 03, 2013
EMBOZENE MICROSPHERES
Celonova Biosciences, Inc.
Cardiovascular
36d
Cleared
Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
28d
Cleared
Jul 02, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
Reverse Medical Corporation
Cardiovascular
204d
Cleared
Jun 17, 2013
AZUR PUSHABLE 18 & 35 SYSTEM
MicroVention, Inc.
Cardiovascular
104d
Cleared
Mar 04, 2013
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
Celonova Biosciences, Inc.
Cardiovascular
25d
Cleared
Jan 03, 2013
RETRACTA DETACHABLE EMBOLIZATION COIL
Cook Incorporated
Cardiovascular
30d
Cleared
Nov 28, 2012
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
MicroVention, Inc.
Cardiovascular
99d
Cleared
Nov 28, 2012
AZUR CX DETACHABLE 18
MicroVention, Inc.
Cardiovascular
26d
Cleared
Aug 29, 2012
AZUR DETACHABLE 35
MicroVention, Inc.
Cardiovascular
28d
Cleared
Jun 12, 2012
AMPLATZER VASCULAR PLUG 4
Aga Medical Corp.
Cardiovascular
183d
Cleared
May 14, 2012
GEL-BLOCK EMBOLIZATION PLEDGETS
Vascular Solutions, Inc.
Cardiovascular
192d
Cleared
Apr 17, 2012
INZONE DETACHMENT SYSTEM
Stryker
Cardiovascular
29d
Cleared
Mar 28, 2012
AZUR DETACHABLE 18
MicroVention, Inc.
Cardiovascular
27d
Cleared
Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corporation
Cardiovascular
30d
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