This guidance document provides recommendations for premarket notification (510(k)) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature.  The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. For the purposes of this guidance, the coronary vasculature includes blood vessels within the heart, including the ostium of the left main coronary artery; the neurovasculature includes blood vessels within the cranium, typically considered the vasculature distal to the cervical segment of the internal carotid artery; the peripheral vasculature includes all other cardiovascular vasculature. This document is intended to assist industry in designing and executing appropriate performance testing to support a 510(k) submission and provides recommendations for content and labeling to include in the submission.