510(k) Report

Devices descending from K991102

34 later devices reach Copilot Bleedback Control Valve, Model 1003331 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073260Liisa Lever Integrated Interventional System Adapter, Model VSL-109Device Partners International20080—
+1K072745Y-GlideThomas Medical Products, Inc.200802
+1K052381Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited200511—
+1K042060Easypass US Y-Connector Hemostatic ValveMillimed A/S200417—
+1K040498MyshellSedat S.A.200412—
+1K031903Rapido Cut-Away Bleedback Control Valve (BBCV), Model 7568Guidant Corporation200401
+1K021282LV-1 Hemostasis Valve, Model #6789Guidant Corp.20020—
+2K143252Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)Needle Tech Products, Inc.20150—
+2K131124ColignJilin Coronado Medical, Ltd.20131—
+2K113148E-PASSSynexmed (Shenzhen)Company Limited20121—
+2K092711Guardian II Hemostasis ValveZerusa Limited20098Class I
+2K080472Sedat Myshell LiteSedat20080—
+2K073620Guardian Hemostasis ValveZerusa Limited200810—
+2K072552Merit Medical Systems, Inc., Guide Wire Torque DeviceMerit Medical Systems, Inc.20073—
+2K060759Y-Click ConnectorElcam Medical Acal20061—
+2K042449Dolphin Inflation DeviceSedat S.A.200554
+3K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd.20160—
+3K122152Oxti Inflation DeviceOxti Corporation20120—
+3K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd.20121Class I
+3K112674Navis TorquerNavis Medical,Inc20120—
+3K100425Haskal Torque DeviceElcam Medical Acal20100—
+3K101113Guardian II NC Hemostasis ValveZerusa Limited20100Class I
+3K100093Vsi Torque DeviceVascular Solutions, Inc.20104—
+3K093822Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist FamilyShepherd Scientific, Inc.20100—
+3K092563Gator Clipseal PlugVascular Solutions, Inc.20090—
+3K082755Sedat FlamingoSedat200831
+4K172453WATCHDOG Hemostasis Valve KitBoston Scientific Corporation201702
+4K152387Fluent Inflation DeviceVascular Solutions, Inc.20151—
+4K141054Distal Access Torque DeviceDistal Access, LLC20143—
+4K123831Ophtacath KitFrance Chirurgae Instrumentation20130—
+5K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd.20220—
+5K170684Firebow Wire Torque Assist DeviceVesatek, LLC20171—
+5K162272Fluent inflation deviceVascular Solutions, Inc.20160—
+6K200120LiteSaber Wire Torque Assist DeviceVesatek, LLC20200—