510(k) Report

Devices descending from K941485

93 later devices reach Cardiometrics Flowire Doppler Guide Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K965140Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc.199792—
+2K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation2008253
+2K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation2008282
+2K041134Combomap Pressure and Flow SystemVolcano Therapeutics, Inc.200485—
+2K021219Smartwire/Smartmap Pressure SystemJomed, Inc.200290—
+2K974241Scimed Informer Pressure Wire SystemScimed Life Systems, Inc.19980—
+3K192340OptoMonitorOpsens, Inc.20197—
+3K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+3K161263OptoMonitor IIOpsens, Inc.20160—
+3K142598Opto Wire and OptoMonitor SystemOpsens, Inc.201512—
+3K123792Horizon Xvu (FFR)Mennen Medical, Ltd.20130—
+3K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+3K100930Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300JVolcano Corporation201014—
+3K081626Flowpicc ConsoleVasonova, Inc.200839—
+3K081625Flowpicc StyletVasonova, Inc.200840—
+3K070487Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation200744—
+3K042996Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide WireVolcano Therapeutics, Inc.200429—
+4K252945Novasight Hybrid SystemConavi Medical, Inc.20260—
+4K201720LiPPS Analyzer, LiPPS Wire Pressure Guide WireBeijing Bywave Sensing Medical Technology Co., Ltd.20210—
+4K202943OptoMonitor 3Opsens, Inc.20205—
+4K193620OptoMonitor 3Opsens, Inc.20206—
+4K152991OptoWire DeuxOpsens20166—
+4K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation20132110
+4K113486Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation20122—
+4K111395Primewire Prestige PlusVolcano Corporation2011131
+4K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc.2011104
+4K103260Vascular Positioning System (VPS System) ConsoleVasonova, Inc.20111—
+4K093510Lumenvu Catheter Guidance SystemSonosite,Inc.20100—
+4K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20093811
+5K213854SavvyWireOpsens, Inc.20224—
+5K191907OptoWire IIIOpsens, Inc.20205—
+5K172397Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20170—
+5K142267Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20141—
+5K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+5K133323Volcano Ifr ModalityVolcano Corporation201418—
+5K133142Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for…Volcano Corporation20130—
+5K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation20130—
+5K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+5K122826Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Volcano Corporation20131—
+5K123813Vascular Positioning System (VPS) G4 ConsoleVasonova, Inc.201301
+5K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+5K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+5K121941Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)2012010
+5K113808The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20126—
+5K093775Evguide Tip Location SystemRomedex International Srl201034—
+6K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+6K241418OptoMonitor 3Opsens, Inc.20251—
+6K240864PacePro WireOpsens, Inc.20240—
+6K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyBard Access Systems, Inc.20220—
+6K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+6K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+6K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+6K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I
+6K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+6K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+6K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+6K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation20159—
+6K143122Volcano iFR Harvest Software (Offline)Volcano Corporation20150—
+6K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc.201581
+6K141634Nautilus DeltaRomedex International Srl20154—
+6K140799Celerity SysyemMedcomp (Medical Components, Inc.)2014131
+6K140345The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20142—
+6K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+6K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc.20117—
+7K251367OptoMonitor 3Opsens, Inc.20260—
+7K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+7K241910Neonav ECG Tip Location SystemNavi Medical Technologies20252—
+7K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+7K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+7K220243Ultiri Measurement SystemAbbott Medical20220—
+7K200037Piccolo Medical SmartPICC SystemPiccolo Medical, Inc.20213—
+7K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+7K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+7K190078IntraSightVolcano Corporation20192—
+7K180560Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc.20181—
+7K171931Celerity ECG Cable Accessory PackMedcomp (Medical Components, Inc.)20170—
+7K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+7K170133FFR V2.5Philips Volcano201751
+7K170385CORE M2 Vascular SystemVolcano Corporation20171—
+7K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+7K152261PICC Tip Positioning AidNostix, LLC20155—
+7K143238C3 WaveMedcomp ( Medical Components)20153—
+8K260929Neonav ECG Tip Location SystemNavi Medical Technologies20260—
+8K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+8K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.20250—
+8K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.20250—
+8K240486PM2 System and ECGuide ConnectorPiccolo Medical, Inc.20242—
+8K203719IntraSight MobileVolcano Corporation202101
+8K170934C3 Wave SystemMedical Components, Inc (Dba Medcomp_201721
+8K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.)20164Class I
+9K241587pilot TLSVygon Corporation20250—
+9K220363VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A subsidiary of Teleflex, Inc.)20220—
+9K180567C3 Wave SystemMedical Components, Inc. (dba MedComp)20180—