510(k) Report

Devices descending from K052381

11 later devices reach Guardian Hemostasis Valve with Guidewire Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092711Guardian II Hemostasis ValveZerusa Limited20098Class I
+1K073620Guardian Hemostasis ValveZerusa Limited200810—
+2K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd.20121Class I
+2K101113Guardian II NC Hemostasis ValveZerusa Limited20100Class I
+2K100093Vsi Torque DeviceVascular Solutions, Inc.20104—
+2K092563Gator Clipseal PlugVascular Solutions, Inc.20090—
+3K172453WATCHDOG Hemostasis Valve KitBoston Scientific Corporation201702
+3K141054Distal Access Torque DeviceDistal Access, LLC20143—
+4K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd.20220—
+4K170684Firebow Wire Torque Assist DeviceVesatek, LLC20171—
+5K200120LiteSaber Wire Torque Assist DeviceVesatek, LLC20200—