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 Boston Scientific Corp, Boston Scientific Corporation and Biosphere Medical, S.A..
128
Total
128
Cleared
121d
Avg days
1985
Since
128 devices
Cleared
Apr 08, 2022
Prestige Coil System
Bait USA, LLC
Cardiovascular
29d
Cleared
Mar 21, 2022
Solus Gold Embolization Device
Artio Medical, Inc.
Cardiovascular
173d
Cleared
Mar 01, 2022
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
Artventive Medical Group, Inc.
Cardiovascular
243d
Cleared
Dec 15, 2021
Merit Siege Vascular Plug
Merit Medical System, Inc.
Cardiovascular
103d
Cleared
Oct 01, 2021
HRSpheres Narrow-Size Embolic Microspheres
Suzhou Hengrui Hongyuan Medical Co., Ltd.
Obstetrics & Gynecology
218d
Cleared
Feb 09, 2021
Concerto Versa, Detachable Coil
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Cardiovascular
134d
Cleared
Nov 05, 2020
LOBO Vascular Occlusion System (model LOBO-5)
Okami Medical
Cardiovascular
34d
Cleared
Mar 20, 2020
AZUR Vascular Plug
MicroVention, Inc.
Cardiovascular
270d
Cleared
Feb 14, 2020
EMBA Hourglass Peripheral Embolization Device (PED)
Embolic Acceleration, LLC
Cardiovascular
30d
Cleared
Feb 04, 2020
The Caterpillar and Caterpillar Micro Arterial Embolization Devices
C.R. Bard, Inc.
Cardiovascular
239d
Cleared
Nov 21, 2019
Torpedo Gelatin Foam
Biosphere Medical, S.A.
Cardiovascular
72d
Cleared
Oct 30, 2019
Okami Medical LOBO Vascular Occlusion System
Okami Medical
Cardiovascular
89d
Cleared
Aug 06, 2019
EmboCube Embolization Gelatin
Biosphere Medical, S.A.
Cardiovascular
270d
Cleared
Jun 18, 2019
Torpedo Gelatin Foam
Biosphere Medical, S.A.
Cardiovascular
179d
Cleared
May 23, 2019
IMPEDE-FX Embolization Plug
Shape Memory Medical
Cardiovascular
261d
Cleared
Apr 17, 2019
Dr. Amplatz Micro Plug
Ka Medical, LLC
Cardiovascular
176d
Cleared
Sep 27, 2018
EmboCube Embolization Gelatin
Biosphere Medical, S.A.
Cardiovascular
163d
Cleared
Jul 16, 2018
Embosphere Microspheres
Biosphere Medical, S.A.
Neurology
60d
Cleared
Jun 22, 2018
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
Shape Memory Medical
Cardiovascular
63d
Cleared
Jan 19, 2018
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
Vascular Solutions, Inc.
Cardiovascular
29d
Cleared
Oct 25, 2017
Gel-Bead
Vascular Solutions, Inc.
Cardiovascular
118d
Cleared
Mar 03, 2017
AZUR CX Detachable 18 Peripheral Coil System
MicroVention, Inc.
Cardiovascular
175d
Cleared
Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
Boston Scientific Corporation
Cardiovascular
134d
Cleared
Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
27d