510(k) Report

Devices descending from K943390

54 later devices reach Flexfinder Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040345Modification to Nitrex Nitinol GuidewireEv3, Inc.200411—
+1K033321Selectiva SB GuidewireNeometrics, Inc.20031—
+1K031864Nitrex Nitinol GuidewireEv3 Corporation200348—
+1K024021Nitrex Nitinol GuidewireEv3 Corporation200349—
+1K991898Ultra-Select Guidewire, Hytek GuidewireMicrovena Corp.19991—
+2K160643ENROUTE 0.014 GuidewireLake Region Medical20161—
+2K110739Entellus Medical Sinus GuidewireEntellus Medical, Inc.20110—
+2K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC200735—
+2K050756Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L.200510—
+2K031442PBN GuidewiresMedical Device Technologies, Inc.20030—
+3K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical20260—
+3K132545Medivalve AcwireMedivalve, Ltd.20130—
+3K122089Ostial Pro Stent Positioning SystemMerit Medical Systems, Inc.20121—
+3K093822Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist FamilyShepherd Scientific, Inc.20100—
+3K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+3K060551Brivant GuidewireBrivant Limited20069—
+4K260289Perfect-O Ostial Positioning CatheterBalosmark, Inc.20260—
+4K110256The IC-Pro SystemPaieon, Inc.201115—
+4K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd.20112—
+4K102211Cruiser 18 GuidewireBrivant, Ltd.20101—
+4K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+4K0935153 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2…Brivant, Ltd.20100—
+4K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+4K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+4K083094Streamer Polymer GuidewireBrivant, Ltd.20093—
+5K141831Hydraview GuidewireBrivant Limited20140—
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K120282CardnavPaieon, Inc.20120—
+5K122856Charter GuidewireBrivant, Ltd.20120—
+5K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+5K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+5K113594C-THV SystemPaieon, Inc.20120—
+5K120137Victory Guidewire (32 Models)Brivant, Ltd.20120—
+5K113076Caas a-ValvePie Medical Imaging BV20121—
+6K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+6K151780CAAS WorkstationPie Medical Imaging BV20169—
+6K143044CAAS A-ValvePie Medical Imaging BV20150—
+6K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+6K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+7K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+7K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+7K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+7K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+8K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+8K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+10K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+10K221711AccuICASArteryFlow Technology Co., Ltd.20230—