510(k) Report

Devices descending from K950113

69 later devices reach Scimed (R) Chice (TM) Exchange Ptca Guide Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022357Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815Boston Scientific, Target200238—
+1K974241Scimed Informer Pressure Wire SystemScimed Life Systems, Inc.19980—
+1K980360Scimed Quest Floppy and Moderate Support Guide WiresScimed Life Systems, Inc.19980—
+1K964551Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice…Scimed Life Systems, Inc.19974—
+1K970244Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc.199710—
+1K962572Scimed Choice PT Vision Ptca Guide WireScimed Life Systems, Inc.1996163
+2K220075Spartan Center WireSpartan Micro, Inc.20220—
+2K112745V-14 Control Wire GuidewireBoston Scientific Corporation20110—
+2K090554Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp20091—
+2K061171Sequitor Steerable Guidewire, Models SQR18XX and SQR14XXBiosphere Medical, Inc.200636—
+2K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc.2003114
+2K021363Endovascular Guide WireStereotaxis, Inc.200286
+2K965023Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireScimed Life Systems, Inc.19972—
+3K180726Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc.20180—
+3K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…Boston Scientific Corporation20150—
+3K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation201561
+3K110479Acuity Whisper View Guide WiresBoston Scientific Corp20110—
+3K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC200735—
+3K043457Modification to Endovascular Guide WireStereotaxis, Inc.20051—
+3K042854Stereotaxis Endovascular Guide WireStereotaxis, Inc.20056—
+3K032183IQ Hydrophilic Guide WireBoston Scientific Corp20034—
+4K170532True Form Reshapable Guide WireMerit Medical Systems, Inc.20170—
+4K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation20162—
+4K132545Medivalve AcwireMedivalve, Ltd.20130—
+4K122089Ostial Pro Stent Positioning SystemMerit Medical Systems, Inc.20121—
+4K093822Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist FamilyShepherd Scientific, Inc.20100—
+4K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+4K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+4K080364Findrwirz Guide Wire SystemSentreheart, Inc.20080Class I
+4K052347Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc.20062—
+4K051373Cronus Guidewire, Model 001-001470-1Stereotaxis, Inc.20050—
+4K040140IQ Guide WireBoston Scientific Corp200431
+5K260289Perfect-O Ostial Positioning CatheterBalosmark, Inc.20260—
+5K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC20190—
+5K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific20180—
+5K110256The IC-Pro SystemPaieon, Inc.201115—
+5K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+5K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+5K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+5K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp20081—
+5K060454Titan GuidewireLake Region Mfg., Inc.20061—
+5K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp20050—
+6K133993Caas WorkstationPie Medical Imaging201410—
+6K120282CardnavPaieon, Inc.20120—
+6K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+6K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+6K113594C-THV SystemPaieon, Inc.20120—
+6K113076Caas a-ValvePie Medical Imaging BV20121—
+6K073655Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc.20080—
+7K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+7K151780CAAS WorkstationPie Medical Imaging BV20169—
+7K143044CAAS A-ValvePie Medical Imaging BV20150—
+7K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+7K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+8K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+8K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+8K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+8K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+8K180019CAAS WorkstationPie Medical Imaging BV20188—
+9K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+9K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+9K251355X1-FFRSpectrawave, Inc.20250—
+9K232147CAAS WorkstationPie Medical Imaging BV20241—
+9K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+10K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+10K243769QFR (3.0)Qfr Solutions BV20250—
+10K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+11K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+11K221711AccuICASArteryFlow Technology Co., Ltd.20230—