510(k) Report

Devices descending from K970376

87 later devices reach Ptca Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082922Freeway and Railrunner GuidewiresLake Region Mfg., Inc.20080—
+1K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001Bridgepoint Medical200813—
+1K041624Ptca Steerable Hydrophilic GuidewireLake Region Mfg., Inc.20044—
+1K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc.2003114
+1K022813Steerable GuidewireLake Region Mfg., Inc.200349—
+1K014210Palmo Thermoregulation Interface AccessoryAvacore Technologies, Inc.20021—
+1K011968Streerable Ptca GuidewireLake Region Mfg., Inc.2001702
+2K180726Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc.20180—
+2K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…Boston Scientific Corporation20150—
+2K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation201561
+2K122795Stingray GuidewiresBridgepoint Medical201201
+2K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+2K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical200912—
+2K052347Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc.20062—
+2K040592Cordis Steer-IT Deflecting Tip GuidewireCordis Corp.20042—
+2K042338Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc.200436—
+2K040345Modification to Nitrex Nitinol GuidewireEv3, Inc.200411—
+2K032183IQ Hydrophilic Guide WireBoston Scientific Corp20034—
+2K023934Rapid Thermal Exchange SystemAvacore Technologies, Inc.20030—
+3K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+3K170532True Form Reshapable Guide WireMerit Medical Systems, Inc.20170—
+3K160643ENROUTE 0.014 GuidewireLake Region Medical20161—
+3K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation20162—
+3K152401Stingray LP CatheterBoston Scientific Corporation20151—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+3K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd.20071—
+3K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC200735—
+3K060454Titan GuidewireLake Region Mfg., Inc.20061—
+3K050756Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L.200510—
+3K040140IQ Guide WireBoston Scientific Corp200431
+4K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical20260—
+4K231176Stingray LP CatheterBoston Scientific20230—
+4K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+4K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+4K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC20190—
+4K183357XableCath Crossing CatheterXablecath, Inc.20190—
+4K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific20180—
+4K171897Approach CTO Microwire GuideCook Incorporated201703
+4K132545Medivalve AcwireMedivalve, Ltd.20130—
+4K122089Ostial Pro Stent Positioning SystemMerit Medical Systems, Inc.20121—
+4K121745Mantaray GuidewiresBridgepoint Medical20120—
+4K093822Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist FamilyShepherd Scientific, Inc.20100—
+4K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+4K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp20081—
+4K073655Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc.20080—
+4K060551Brivant GuidewireBrivant Limited20069—
+4K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp20050—
+5K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+5K260289Perfect-O Ostial Positioning CatheterBalosmark, Inc.20260—
+5K110256The IC-Pro SystemPaieon, Inc.201115—
+5K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd.20112—
+5K102211Cruiser 18 GuidewireBrivant, Ltd.20101—
+5K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+5K0935153 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2…Brivant, Ltd.20100—
+5K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+5K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+5K083094Streamer Polymer GuidewireBrivant, Ltd.20093—
+6K141831Hydraview GuidewireBrivant Limited20140—
+6K133993Caas WorkstationPie Medical Imaging201410—
+6K120282CardnavPaieon, Inc.20120—
+6K122856Charter GuidewireBrivant, Ltd.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—
+6K120137Victory Guidewire (32 Models)Brivant, Ltd.20120—
+6K113076Caas a-ValvePie Medical Imaging BV20121—
+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—