510(k) Report

Devices descending from K961445

51 later devices reach Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063695Runthrough NSTerumo Medical Corp.2007311
+1K014195Kayak Hydrophilic Guide WiresBoston Scientific Corp20020—
+1K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp.199817—
+2K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies201113—
+2K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc.200812—
+2K080563Runthrough NS Extension WireTerumo Medical Corp.20085—
+2K062582Supracor Balloon CatheterAbiomed, Inc.20061—
+2K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp.200015—
+3K152709HI-Torque BalanceAbbott Vascular20152—
+3K141782HI-Torque Versaturn Guide WireAbbott Vascular20141—
+3K133725Traxcess 14 GuidewireMicroVention, Inc.20149—
+3K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+3K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+3K093647Traxcess Docking WireMicroVention, Inc.20102—
+3K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc.20091—
+3K082746Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20Insightra Medical, Inc.200901
+3K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp.200114—
+4K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—
+4K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+4K200374Columbus GuidewireRapid-Medical, Ltd.20200—
+4K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+4K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited20190—
+4K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+4K182337HYBRID GuidewireBalt USA, LLC20181—
+4K173795HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular20180—
+4K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—
+4K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+4K153053Traxcess Pro 14 GuidewireMicroVention, Inc.20154—
+4K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+4K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+4K112219Tapas CatheterThermopeutix, Inc.20111—
+4K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division20093—
+4K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.20078Class I
+4K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp.2004117
+4K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp.200312—
+4K020257Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…Datascope Corp.20020—
+5K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd.20260—
+5K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+5K200547Traxcess 14 SELECT GuidewireMicroVention, Inc.20200—
+5K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.201702
+5K161803Traxcess .007 Mini GuidewireMicroVention, Inc.201621
+5K141175Renovocath RC120Renovorx, Inc.201401
+5K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp.201309
+5K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC20113Class I
+5K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC201121
+6K201487Traxcess 7 Mini GuidewireMicroVention, Inc.20200—
+6K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.20180Class I
+6K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc.20160—
+6K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.20151Class I
+6K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203
+7K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp.20170Class I