Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

Issue Date: February 15, 2008
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k)
Status: Final

Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

FDA has developed this guidance document to assist industry in preparing premarket notification submissions for Coronary and Carotid Embolic Protection Devices. These devices are designed to capture and remove embolic material that may be dislodged during the interventional treatment of carotid arteries or saphenous vein bypass grafts with the intention of reducing the incidence of adverse cardiac or cerebrovascular events. We recommend that members of industry and FDA staff who perform or review clinical and non-clinical evaluations and prepare labeling of coronary and carotid embolic protection devices should use this guidance.

Download the Guidance Document