510(k) Report

Devices descending from K092711

8 later devices reach Guardian II Hemostasis Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd.20121Class I
+1K101113Guardian II NC Hemostasis ValveZerusa Limited20100Class I
+1K100093Vsi Torque DeviceVascular Solutions, Inc.20104—
+2K172453WATCHDOG Hemostasis Valve KitBoston Scientific Corporation201702
+2K141054Distal Access Torque DeviceDistal Access, LLC20143—
+3K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd.20220—
+3K170684Firebow Wire Torque Assist DeviceVesatek, LLC20171—
+4K200120LiteSaber Wire Torque Assist DeviceVesatek, LLC20200—