510(k) Report

Devices descending from K953533

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0935153 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2…Brivant, Ltd.20100—
+1K961445Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp.199651—
+2K063695Runthrough NSTerumo Medical Corp.2007311
+2K014195Kayak Hydrophilic Guide WiresBoston Scientific Corp20020—
+2K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp.199817—
+3K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies201113—
+3K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc.200812—
+3K080563Runthrough NS Extension WireTerumo Medical Corp.20085—
+3K062582Supracor Balloon CatheterAbiomed, Inc.20061—
+3K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp.200015—
+4K152709HI-Torque BalanceAbbott Vascular20152—
+4K141782HI-Torque Versaturn Guide WireAbbott Vascular20141—
+4K133725Traxcess 14 GuidewireMicroVention, Inc.20149—
+4K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+4K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+4K093647Traxcess Docking WireMicroVention, Inc.20102—
+4K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc.20091—
+4K082746Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20Insightra Medical, Inc.200901
+4K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp.200114—
+5K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—
+5K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+5K200374Columbus GuidewireRapid-Medical, Ltd.20200—
+5K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+5K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited20190—
+5K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+5K182337HYBRID GuidewireBalt USA, LLC20181—
+5K173795HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular20180—
+5K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—
+5K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+5K153053Traxcess Pro 14 GuidewireMicroVention, Inc.20154—
+5K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+5K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+5K112219Tapas CatheterThermopeutix, Inc.20111—
+5K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division20093—
+5K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.20078Class I
+5K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp.2004117
+5K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp.200312—
+5K020257Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…Datascope Corp.20020—
+6K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd.20260—
+6K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+6K200547Traxcess 14 SELECT GuidewireMicroVention, Inc.20200—
+6K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.201702
+6K161803Traxcess .007 Mini GuidewireMicroVention, Inc.201621
+6K141175Renovocath RC120Renovorx, Inc.201401
+6K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp.201309
+6K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC20113Class I
+6K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC201121
+7K201487Traxcess 7 Mini GuidewireMicroVention, Inc.20200—
+7K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.20180Class I
+7K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc.20160—
+7K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.20151Class I
+7K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203
+8K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp.20170Class I