510(k) K161287

DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak by Medtronic Vascular — Product Code DQO

K161287 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak". The FDA issued a decision of Substantially Equivalent (kit) on August 19, 2016. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Medtronic Vascular has at least 10 other 510(k) clearances on record.