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., Boston Scientific Corp and Cook, Inc..

132
Total
132
Cleared
121d
Avg days
1985
Since
132 devices
49–72 of 132
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 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 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 22, 2015
Retracta Detachable Embolization Coil
K151676
Cook Incorporated
Cardiovascular · 30d
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 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 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 Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578
Boston Scientific Corp
Cardiovascular · 28d
Cleared Jun 17, 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577
MicroVention, Inc.
Cardiovascular · 104d
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 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