This document specifies the technical requirements, inspection methods, inspection rules, markings, labels, instructions for use, packaging, transportation and storage requirements for intracranial blood flow guiding dense mesh stents. This document applies to blood flow-directing dense-mesh stents for the treatment of intracranial aneurysms, including stents and supporting delivery systems. This document does not include access devices (such as microcatheters) and other ancillary devices used to deliver stents.