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 Cook, Inc..
132
Total
132
Cleared
121d
Avg days
1985
Since
132 devices
Cleared
Oct 25, 2017
Gel-Bead
Vascular Solutions, Inc.
Cardiovascular
118d
Cleared
Sep 06, 2017
QuadraSphere Microspheres
Biosphere Medical, S.A.
Neurology
30d
Cleared
Aug 18, 2017
EMBA Hourglass Peripheral Embolization Device
Emba Medical Limited
Cardiovascular
59d
Cleared
Mar 03, 2017
AZUR CX Detachable 18 Peripheral Coil System
MicroVention, Inc.
Cardiovascular
175d
Cleared
Dec 16, 2016
LC Bead LUMI
Biocompatibles UK Limited
Cardiovascular
114d
Cleared
Aug 03, 2016
Hilal Embolization MicroCoils
Cook Incorporated
Cardiovascular
187d
Cleared
May 19, 2016
Nester Embolization Coils, Tornado Embolization Coils
Cook Incorporated
Cardiovascular
140d
Cleared
Mar 07, 2016
Bead Block
Biocompatibles UK , Ltd.
Neurology
341d
Cleared
Dec 21, 2015
HydroPearl Microspheres, HydroPearl Microspheres
MicroVention, Inc.
Cardiovascular
264d
Cleared
Dec 18, 2015
MReye Embolization Coils
Cook Incorporated
Cardiovascular
256d
Cleared
Dec 18, 2015
MReye Flipper Detachable Embolization Coil and Delivery System
Cook Incorporated
Cardiovascular
252d
Cleared
Dec 11, 2015
LC Bead LUMI
Biocompatibles UK , Ltd.
Cardiovascular
130d
Cleared
Nov 23, 2015
QuadraSphere Microspheres
Biosphere Medical, S.A.
Neurology
28d
Cleared
Sep 25, 2015
Endoluminal Occlusion System-EOS
Artventive Medical Group, Inc.
Cardiovascular
219d
Cleared
Sep 25, 2015
AZUR CX Detachable 35 Coils
MicroVention, Inc.
Cardiovascular
128d
Cleared
Sep 17, 2015
LifePearl Microshperes
MicroVention, Inc.
Cardiovascular
161d
Cleared
Jul 27, 2015
QuadraSphere Microspheres
Biosphere Medical, S.A.
Neurology
84d
Cleared
Jul 22, 2015
Retracta Detachable Embolization Coil
Cook Incorporated
Cardiovascular
30d
Cleared
Apr 22, 2015
Reverse Medical Micro Vascular Plug System
Reverse Medical Corporation
Cardiovascular
92d
Cleared
Dec 03, 2014
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
Artventive Medical Group, Inc.
Cardiovascular
345d
Cleared
Dec 02, 2014
MEDUSA VASCULAR PLUG,
Endoshape, Inc.
Cardiovascular
246d
Cleared
Nov 20, 2014
Gel-Block 10X embolization pledgets
Vascular Solutions, Inc.
Cardiovascular
29d
Cleared
Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
Boston Scientific Corporation
Cardiovascular
134d
Cleared
Aug 07, 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES
Celonova Biosciences, Inc.
Cardiovascular
90d