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., Biosphere Medical, S.A. and Cook, Inc..

132
Total
132
Cleared
121d
Avg days
1985
Since
132 devices
49–72 of 132
Cleared Oct 25, 2017
Gel-Bead
K171946
Vascular Solutions, Inc.
Cardiovascular · 118d
Cleared Sep 06, 2017
QuadraSphere Microspheres
K172372
Biosphere Medical, S.A.
Neurology · 30d
Cleared Aug 18, 2017
EMBA Hourglass Peripheral Embolization Device
K171845
Emba Medical Limited
Cardiovascular · 59d
Cleared Mar 03, 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524
MicroVention, Inc.
Cardiovascular · 175d
Cleared Dec 16, 2016
LC Bead LUMI
K162373
Biocompatibles UK Limited
Cardiovascular · 114d
Cleared Aug 03, 2016
Hilal Embolization MicroCoils
K160219
Cook Incorporated
Cardiovascular · 187d
Cleared May 19, 2016
Nester Embolization Coils, Tornado Embolization Coils
K153778
Cook Incorporated
Cardiovascular · 140d
Cleared Mar 07, 2016
Bead Block
K150876
Biocompatibles UK , Ltd.
Neurology · 341d
Cleared Dec 21, 2015
HydroPearl Microspheres, HydroPearl Microspheres
K150870
MicroVention, Inc.
Cardiovascular · 264d
Cleared Dec 18, 2015
MReye Embolization Coils
K150931
Cook Incorporated
Cardiovascular · 256d
Cleared Dec 18, 2015
MReye Flipper Detachable Embolization Coil and Delivery System
K150964
Cook Incorporated
Cardiovascular · 252d
Cleared Dec 11, 2015
LC Bead LUMI
K152157
Biocompatibles UK , Ltd.
Cardiovascular · 130d
Cleared Nov 23, 2015
QuadraSphere Microspheres
K153102
Biosphere Medical, S.A.
Neurology · 28d
Cleared Sep 25, 2015
Endoluminal Occlusion System-EOS
K150402
Artventive Medical Group, Inc.
Cardiovascular · 219d
Cleared Sep 25, 2015
AZUR CX Detachable 35 Coils
K151358
MicroVention, Inc.
Cardiovascular · 128d
Cleared Sep 17, 2015
LifePearl Microshperes
K150958
MicroVention, Inc.
Cardiovascular · 161d
Cleared Jul 27, 2015
QuadraSphere Microspheres
K151187
Biosphere Medical, S.A.
Neurology · 84d
Cleared Jul 22, 2015
Retracta Detachable Embolization Coil
K151676
Cook Incorporated
Cardiovascular · 30d
Cleared Apr 22, 2015
Reverse Medical Micro Vascular Plug System
K150108
Reverse Medical Corporation
Cardiovascular · 92d
Cleared Dec 03, 2014
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
K133924
Artventive Medical Group, Inc.
Cardiovascular · 345d
Cleared Dec 02, 2014
MEDUSA VASCULAR PLUG,
K140796
Endoshape, Inc.
Cardiovascular · 246d
Cleared Nov 20, 2014
Gel-Block 10X embolization pledgets
K143038
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
K141378
Boston Scientific Corporation
Cardiovascular · 134d
Cleared Aug 07, 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES
K141209
Celonova Biosciences, Inc.
Cardiovascular · 90d