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 Corporation, Varian Medical Systems, Inc. and Instylla, Inc..
FDA 510(k) Cleared Device, Vascular, For Promoting Embolization Devices (Product Code KRD)
About Product Code KRD - Regulatory Context
510(k) Submission Activity
128 total 510(k) submissions under product code KRD since 1985, with 128 receiving FDA clearance (average review time: 121 days).
Submission volume has increased in recent years - 15 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KRD have taken an average of 103 days to reach a decision - down from 123 days historically, suggesting improved FDA processing for this classification.
KRD devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →