FDA Product Code MOF: Guide, Wire, Catheter, Neurovasculature
Leading manufacturers include Scientia Vascular, Inc., Arbor Endovascular, LLC and Asahi Intecc Co., Ltd..
FDA 510(k) Cleared Guide, Wire, Catheter, Neurovasculature Devices (Product Code MOF)
About Product Code MOF - Regulatory Context
510(k) Submission Activity
40 total 510(k) submissions under product code MOF since 2011, with 40 receiving FDA clearance (average review time: 127 days).
Submission volume has increased in recent years - 13 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MOF have taken an average of 170 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
MOF devices are reviewed by the Neurology panel. Browse all Neurology devices →