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 Boston Scientific Corp, Boston Scientific Corporation and Biosphere Medical, S.A..

128
Total
128
Cleared
121d
Avg days
1985
Since
128 devices
25–48 of 128
Cleared Apr 08, 2022
Prestige Coil System
K220699
Bait USA, LLC
Cardiovascular · 29d
Cleared Mar 21, 2022
Solus Gold Embolization Device
K213200
Artio Medical, Inc.
Cardiovascular · 173d
Cleared Mar 01, 2022
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
K212057
Artventive Medical Group, Inc.
Cardiovascular · 243d
Cleared Dec 15, 2021
Merit Siege Vascular Plug
K212817
Merit Medical System, Inc.
Cardiovascular · 103d
Cleared Oct 01, 2021
HRSpheres Narrow-Size Embolic Microspheres
K210562
Suzhou Hengrui Hongyuan Medical Co., Ltd.
Obstetrics & Gynecology · 218d
Cleared Feb 09, 2021
Concerto Versa, Detachable Coil
K202850
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Cardiovascular · 134d
Cleared Nov 05, 2020
LOBO Vascular Occlusion System (model LOBO-5)
K203025
Okami Medical
Cardiovascular · 34d
Cleared Mar 20, 2020
AZUR Vascular Plug
K191680
MicroVention, Inc.
Cardiovascular · 270d
Cleared Feb 14, 2020
EMBA Hourglass Peripheral Embolization Device (PED)
K200083
Embolic Acceleration, LLC
Cardiovascular · 30d
Cleared Feb 04, 2020
The Caterpillar and Caterpillar Micro Arterial Embolization Devices
K191532
C.R. Bard, Inc.
Cardiovascular · 239d
Cleared Nov 21, 2019
Torpedo Gelatin Foam
K192480
Biosphere Medical, S.A.
Cardiovascular · 72d
Cleared Oct 30, 2019
Okami Medical LOBO Vascular Occlusion System
K192083
Okami Medical
Cardiovascular · 89d
Cleared Aug 06, 2019
EmboCube Embolization Gelatin
K183120
Biosphere Medical, S.A.
Cardiovascular · 270d
Cleared Jun 18, 2019
Torpedo Gelatin Foam
K183578
Biosphere Medical, S.A.
Cardiovascular · 179d
Cleared May 23, 2019
IMPEDE-FX Embolization Plug
K182390
Shape Memory Medical
Cardiovascular · 261d
Cleared Apr 17, 2019
Dr. Amplatz Micro Plug
K182944
Ka Medical, LLC
Cardiovascular · 176d
Cleared Sep 27, 2018
EmboCube Embolization Gelatin
K181021
Biosphere Medical, S.A.
Cardiovascular · 163d
Cleared Jul 16, 2018
Embosphere Microspheres
K181300
Biosphere Medical, S.A.
Neurology · 60d
Cleared Jun 22, 2018
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
K181051
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
K173891
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Oct 25, 2017
Gel-Bead
K171946
Vascular Solutions, Inc.
Cardiovascular · 118d
Cleared Mar 03, 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524
MicroVention, Inc.
Cardiovascular · 175d
Cleared Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
K141378
Boston Scientific Corporation
Cardiovascular · 134d
Cleared Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208
Boston Scientific Corp
Cardiovascular · 27d