510(k) Report

Devices descending from K854261

37 later devices reach Advanced Cardiovascular Systems Hemostatic Valves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031688Rapido Cut-a-Way Rotating Hemostasis ValveGuidant Corporation200311
+1K991102Copilot Bleedback Control Valve, Model 1003331Guidant Corp.1999341
+2K073260Liisa Lever Integrated Interventional System Adapter, Model VSL-109Device Partners International20080—
+2K072745Y-GlideThomas Medical Products, Inc.200802
+2K0524596248VAL Adjustable ValveMedtronic Vascular200601
+2K052381Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited200511—
+2K042060Easypass US Y-Connector Hemostatic ValveMillimed A/S200417—
+2K040498MyshellSedat S.A.200412—
+2K031903Rapido Cut-Away Bleedback Control Valve (BBCV), Model 7568Guidant Corporation200401
+2K021282LV-1 Hemostasis Valve, Model #6789Guidant Corp.20020—
+3K143252Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)Needle Tech Products, Inc.20150—
+3K131124ColignJilin Coronado Medical, Ltd.20131—
+3K113148E-PASSSynexmed (Shenzhen)Company Limited20121—
+3K092711Guardian II Hemostasis ValveZerusa Limited20098Class I
+3K080472Sedat Myshell LiteSedat20080—
+3K073620Guardian Hemostasis ValveZerusa Limited200810—
+3K072552Merit Medical Systems, Inc., Guide Wire Torque DeviceMerit Medical Systems, Inc.20073—
+3K060759Y-Click ConnectorElcam Medical Acal20061—
+3K042449Dolphin Inflation DeviceSedat S.A.200554
+4K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd.20160—
+4K122152Oxti Inflation DeviceOxti Corporation20120—
+4K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd.20121Class I
+4K112674Navis TorquerNavis Medical,Inc20120—
+4K100425Haskal Torque DeviceElcam Medical Acal20100—
+4K101113Guardian II NC Hemostasis ValveZerusa Limited20100Class I
+4K100093Vsi Torque DeviceVascular Solutions, Inc.20104—
+4K093822Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist FamilyShepherd Scientific, Inc.20100—
+4K092563Gator Clipseal PlugVascular Solutions, Inc.20090—
+4K082755Sedat FlamingoSedat200831
+5K172453WATCHDOG Hemostasis Valve KitBoston Scientific Corporation201702
+5K152387Fluent Inflation DeviceVascular Solutions, Inc.20151—
+5K141054Distal Access Torque DeviceDistal Access, LLC20143—
+5K123831Ophtacath KitFrance Chirurgae Instrumentation20130—
+6K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd.20220—
+6K170684Firebow Wire Torque Assist DeviceVesatek, LLC20171—
+6K162272Fluent inflation deviceVascular Solutions, Inc.20160—
+7K200120LiteSaber Wire Torque Assist DeviceVesatek, LLC20200—