510(k) Report

Devices descending from K100093

4 later devices reach Vsi Torque Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141054Distal Access Torque DeviceDistal Access, LLC20143—
+2K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd.20220—
+2K170684Firebow Wire Torque Assist DeviceVesatek, LLC20171—
+3K200120LiteSaber Wire Torque Assist DeviceVesatek, LLC20200—