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 Boston Scientific Corp.

132
Total
132
Cleared
121d
Avg days
1985
Since
132 devices
73–96 of 132
Cleared Jun 18, 2014
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
K141313
Reverse Medical Corporation
Cardiovascular · 29d
Cleared Apr 25, 2014
GEL-BEAD EMBOLIZATION SPHERES
K133237
Vascular Solutions, Inc.
Cardiovascular · 186d
Cleared Dec 20, 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626
MicroVention, Inc.
Cardiovascular · 24d
Cleared Nov 27, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K133282
Reverse Medical Corporation
Cardiovascular · 33d
Cleared Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208
Boston Scientific Corp
Cardiovascular · 27d
Cleared Oct 28, 2013
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
K132083
MicroVention, Inc.
Cardiovascular · 115d
Cleared Oct 25, 2013
MEDUSA VASCULAR PLUG
K123696
Endoshape, Inc.
Cardiovascular · 326d
Cleared Oct 03, 2013
EMBOZENE MICROSPHERES
K132675
Celonova Biosciences, Inc.
Cardiovascular · 36d
Cleared Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578
Boston Scientific Corp
Cardiovascular · 28d
Cleared Jul 02, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K123803
Reverse Medical Corporation
Cardiovascular · 204d
Cleared Jun 17, 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577
MicroVention, Inc.
Cardiovascular · 104d
Cleared Mar 04, 2013
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
K130307
Celonova Biosciences, Inc.
Cardiovascular · 25d
Cleared Jan 03, 2013
RETRACTA DETACHABLE EMBOLIZATION COIL
K123712
Cook Incorporated
Cardiovascular · 30d
Cleared Nov 28, 2012
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K122543
MicroVention, Inc.
Cardiovascular · 99d
Cleared Nov 28, 2012
AZUR CX DETACHABLE 18
K123384
MicroVention, Inc.
Cardiovascular · 26d
Cleared Aug 29, 2012
AZUR DETACHABLE 35
K122316
MicroVention, Inc.
Cardiovascular · 28d
Cleared Jun 12, 2012
AMPLATZER VASCULAR PLUG 4
K113658
Aga Medical Corp.
Cardiovascular · 183d
Cleared May 14, 2012
GEL-BLOCK EMBOLIZATION PLEDGETS
K113266
Vascular Solutions, Inc.
Cardiovascular · 192d
Cleared Apr 17, 2012
INZONE DETACHMENT SYSTEM
K120816
Stryker
Cardiovascular · 29d
Cleared Mar 28, 2012
AZUR DETACHABLE 18
K120630
MicroVention, Inc.
Cardiovascular · 27d
Cleared Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103
Boston Scientific Corp
Cardiovascular · 21d
Cleared Jun 15, 2011
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
K111307
MicroVention, Inc.
Cardiovascular · 36d
Cleared Mar 03, 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
K102912
Boston Scientific
Cardiovascular · 153d