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
Cleared
Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
28d
Cleared
Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corporation
Cardiovascular
30d
Cleared
Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
21d
Cleared
Mar 03, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corp
Cardiovascular
30d
Cleared
Feb 11, 2011
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
Boston Scientific Corp
Cardiovascular
144d
Cleared
Jan 31, 2006
FIBERED IDC OCCLUSION SYSTEM
Boston Scientific Corporation
Cardiovascular
21d
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