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
Cleared
Aug 03, 2016
Hilal Embolization MicroCoils
Cook Incorporated
Cardiovascular
187d
Cleared
May 19, 2016
Nester Embolization Coils, Tornado Embolization Coils
Cook Incorporated
Cardiovascular
140d
Cleared
Dec 21, 2015
HydroPearl Microspheres, HydroPearl Microspheres
MicroVention, Inc.
Cardiovascular
264d
Cleared
Dec 18, 2015
MReye Embolization Coils
Cook Incorporated
Cardiovascular
256d
Cleared
Dec 18, 2015
MReye Flipper Detachable Embolization Coil and Delivery System
Cook Incorporated
Cardiovascular
252d
Cleared
Sep 25, 2015
AZUR CX Detachable 35 Coils
MicroVention, Inc.
Cardiovascular
128d
Cleared
Sep 17, 2015
LifePearl Microshperes
MicroVention, Inc.
Cardiovascular
161d
Cleared
Jul 22, 2015
Retracta Detachable Embolization Coil
Cook Incorporated
Cardiovascular
30d
Cleared
Nov 20, 2014
Gel-Block 10X embolization pledgets
Vascular Solutions, Inc.
Cardiovascular
29d
Cleared
Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
Boston Scientific Corporation
Cardiovascular
134d
Cleared
Apr 25, 2014
GEL-BEAD EMBOLIZATION SPHERES
Vascular Solutions, Inc.
Cardiovascular
186d
Cleared
Dec 20, 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
MicroVention, Inc.
Cardiovascular
24d
Cleared
Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
27d
Cleared
Oct 28, 2013
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
MicroVention, Inc.
Cardiovascular
115d
Cleared
Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
28d
Cleared
Jun 17, 2013
AZUR PUSHABLE 18 & 35 SYSTEM
MicroVention, Inc.
Cardiovascular
104d
Cleared
Jan 03, 2013
RETRACTA DETACHABLE EMBOLIZATION COIL
Cook Incorporated
Cardiovascular
30d
Cleared
Nov 28, 2012
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
MicroVention, Inc.
Cardiovascular
99d
Cleared
Nov 28, 2012
AZUR CX DETACHABLE 18
MicroVention, Inc.
Cardiovascular
26d
Cleared
Aug 29, 2012
AZUR DETACHABLE 35
MicroVention, Inc.
Cardiovascular
28d
Cleared
May 14, 2012
GEL-BLOCK EMBOLIZATION PLEDGETS
Vascular Solutions, Inc.
Cardiovascular
192d
Cleared
Apr 17, 2012
INZONE DETACHMENT SYSTEM
Stryker
Cardiovascular
29d
Cleared
Mar 28, 2012
AZUR DETACHABLE 18
MicroVention, Inc.
Cardiovascular
27d
Cleared
Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corporation
Cardiovascular
30d