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.
133
Total
133
Cleared
121d
Avg days
1985
Since
133 devices
Cleared
Apr 13, 2004
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
Boston Scientific Corp
Cardiovascular
61d
Cleared
Mar 26, 2004
CONTOUR SE MICROSPHERES
Boston Scientific Corp
Cardiovascular
86d
Cleared
Sep 09, 2003
AMPLATZER VASCULAR PLUG
Aga Medical Corp.
Cardiovascular
89d
Cleared
Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
Cook, Inc.
Cardiovascular
90d
Cleared
Dec 20, 1999
EMBOLIZATION COIL SYSTEM
Cook, Inc.
Cardiovascular
180d
Cleared
Feb 26, 1997
BERENSTEIN COIL
Target Therapeutics
Cardiovascular
134d
Cleared
Feb 06, 1996
FIBERED PLATINUM COIL, .035 TYPE
Target Therapeutics
Cardiovascular
82d
Cleared
Nov 28, 1994
COIL POSITIONER SET
Cook, Inc.
Cardiovascular
319d
Cleared
Oct 14, 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
Cook, Inc.
Cardiovascular
227d
Cleared
Apr 20, 1992
TARGET THERAPEUTICS COILS
Target Therapeutics
Cardiovascular
180d
Cleared
Jul 14, 1989
SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02
Shiley, Inc.
Cardiovascular
95d
Cleared
Aug 11, 1988
INTERSEPT* OXYGEN GAS LINE FILTER
Medtronic Blood Systems, Inc.
Cardiovascular
83d
Cleared
Nov 22, 1985
SILICONE OIL 350 CNETISTOKE
Pacific Medical Industries
Cardiovascular
63d