Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- K254085CARTO™ 3 EP Navigation System V9.0 with PIU Plus2Cleared 510(K)
- K253733STAR Apollo™ Mapping System2Cleared 510(K)
- K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)2Cleared 510(K)
- K253141DeepRhythmAI2Cleared 510(K)
- K252429Vektor Computational ECG Mapping System (vMap®)2Cleared 510(K)
- K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub2Cleared 510(K)
- K252238CoroFlow Cardiovascular System2Cleared 510(K)
- K253034HemoSphere Stream Module2Cleared 510(K)
- K252013EnSite™ X EP System2Cleared 510(K)
- K251518Volta AF-Xplorer II2Cleared 510(K)
- K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)2Cleared 510(K)
- K252302CARTO™ 3 EP Navigation System V8.12Cleared 510(K)
- K251234EnSite™ X EP System2Cleared 510(K)
- K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)2Cleared 510(K)
- K250747Globe® Pulsed Field System2Cleared 510(K)
- K250749PhysCade System2Cleared 510(K)
- K251344OptiMap™ System2Cleared 510(K)
- K250932DeepRhythmAI2Cleared 510(K)
- K243812Volta AF-Xplorer2Cleared 510(K)
- K242129VitalRhythm2Cleared 510(K)
- K243842Intra-Operative Positioning System (IOPS®)2Cleared 510(K)
- K243312CER-S2Cleared 510(K)
- K243892Affera Integrated Mapping System2Cleared 510(K)
- K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)2Cleared 510(K)
- K243435Magnetic Localization Patch Kit (AFR-00021)2Cleared 510(K)
- K241197DeepRhythmAI2Cleared 510(K)
- K241828Affera Integrated Mapping System; Impedance Localization Patch Kit2Cleared 510(K)
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)2Cleared 510(K)
- K241227RHYTHMIA HDx™ Mapping System2Cleared 510(K)
- K233755HeartKey® Rhythm2Cleared 510(K)
- K242016EnSite™ X EP System2Cleared 510(K)
- K240509STAR Apollo™ Mapping System2Cleared 510(K)
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)2Cleared 510(K)
- K233326Merge Hemo, Model RCSV22Cleared 510(K)
- K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub2Cleared 510(K)
- K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)2Cleared 510(K)
- K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System2Cleared 510(K)
- K233160NeuTrace EP Mapping System v.2.12Cleared 510(K)
- K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)2Cleared 510(K)
- K232616Volta AF-Xplorer2Cleared 510(K)
- K230884AVVIGO'+ Multi-Modality Guidance System2Cleared 510(K)
- K223812Sensis Vibe (VD15)2Cleared 510(K)
- K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)2Cleared 510(K)
- K230579Smart Wedge algorithm2Cleared 510(K)
- K231415EnSite™ X EP System2Cleared 510(K)
- K223787ECGenius System2Cleared 510(K)
- K231620Nuubo Smart2Cleared 510(K)
- K231035FusedCO Algorithm2Cleared 510(K)
- K231091AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)2Cleared 510(K)
- K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor2Cleared 510(K)
- K230008Ablamap® System2Cleared 510(K)
- K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub2Cleared 510(K)
- K230606AcQMap® High Resolution Imaging and Mapping System2Cleared 510(K)
- K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.42Cleared 510(K)
- K222389ZEUS System2Cleared 510(K)
- K223516VX1+2Cleared 510(K)
- K211557EndoPATx2Cleared 510(K)
- K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License2Cleared 510(K)
- K220786STAR Apollo Mapping System2Cleared 510(K)
- K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)2Cleared 510(K)
- K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable2Cleared 510(K)
- K212493KODEX – EPD™ System 1.5.02Cleared 510(K)
- K222209AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K221213EnSite X EP System2Cleared 510(K)
- K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)2Cleared 510(K)
- K210822DeepRhythmAI2Cleared 510(K)
- K213409ZEUS System (Zio Watch)2Cleared 510(K)
- K220784AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote2Cleared 510(K)
- K220306ECGenius System2Cleared 510(K)
- K220243Ultiri Measurement System2Cleared 510(K)
- K212662AliveCor QT Service2Cleared 510(K)
- K213861CER-S2Cleared 510(K)
- K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX2Cleared 510(K)
- K202094Cardiovascular Suite 4.2.12Cleared 510(K)
- K213364EnSite X EP System2Cleared 510(K)
- K211546Vektor Computational ECG Mapping System (vMap)2Cleared 510(K)
- K210543IM0072Cleared 510(K)
- K213264CARTO 3 EP Navigation System Version 7.22Cleared 510(K)
- K212061EnSite X EP System2Cleared 510(K)
- K212490AVVIGO Guidance System II2Cleared 510(K)
- K203084Ablamap Software2Cleared 510(K)
- K212345AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K201094iMap 3D Mapping & Navigation System (iMap System)2Cleared 510(K)
- K210680AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform2Cleared 510(K)
- K210889iLab Polaris Multi-Modality Guidance System2Cleared 510(K)
- K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index2Cleared 510(K)
- K202527Zio ECG Utilization Software (ZEUS) System2Cleared 510(K)
- K201921Spacelabs Lifescreen PRO Analyzer2Cleared 510(K)
- K210392WorkMate Claris System2Cleared 510(K)
- K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter2Cleared 510(K)
- K202189Graffiti2Cleared 510(K)
- K201015AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled2Cleared 510(K)
- K200484CARTO® 3 EP Navigation System with Signal Processing Unit2Cleared 510(K)
- K201060Cordiana Dx162Cleared 510(K)
- K201881CoroFlow Cardiovascular System2Cleared 510(K)
- K201985KardiaAI2Cleared 510(K)
- K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module2Cleared 510(K)
- K201298VX12Cleared 510(K)
- K200313VIVO2Cleared 510(K)
- K201713AVVIGO Guidance System2Cleared 510(K)
- K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System2Cleared 510(K)
- K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License2Cleared 510(K)
- K201178iLab Polaris Multi-Modality Guidance System2Cleared 510(K)
- K193013AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K192438Rhythmia HDxTM Mapping System2Cleared 510(K)
- K191392AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module2Cleared 510(K)
- K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring System2Cleared 510(K)
- K191660CARTO 3 EP Navigation System, Version 7.1 and Accessories2Cleared 510(K)
- K191008iLab Polaris Multi-Modality Guidance System2Cleared 510(K)
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle2Cleared 510(K)
- K183195VIVO2Cleared 510(K)
- K191089Edwards Pressure Cable2Cleared 510(K)
- K190131AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K181823KardiaAI2Cleared 510(K)
- K182344RhythmAnalytics2Cleared 510(K)
- K183266EP-TRACER System2Cleared 510(K)
- K183099QUANTIEN Measurement System2Cleared 510(K)
- K181577AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.22Cleared 510(K)
- K180432AI-ECG Platform2Cleared 510(K)
- K180881HemoSphere Advanced Monitor, HemoSphere Pressure Cable2Cleared 510(K)
- K181918CardioInsight Cardiac Mapping System2Cleared 510(K)
- K180940KODEX EPD System2Cleared 510(K)
- K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.22Cleared 510(K)
- K181502Zio AT ECG Monitoring System, ZEUS System2Cleared 510(K)
- K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module2Cleared 510(K)
- K180805Pure EP2Cleared 510(K)
- K181720Epiphany Cardio Server Mobile2Cleared 510(K)
- K173837RHYTHMIA HDx Mapping System (with software Version 2.0)2Cleared 510(K)
- K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module2Cleared 510(K)
- K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT2Cleared 510(K)
- K172396EnSite Velocity Cardiac Mapping System v5.22Cleared 510(K)
- K170948AcQMap High Resolution Imaging and Mapping System2Cleared 510(K)
- K171583RhythmView Workstation2Cleared 510(K)
- K172182QUANTIEN Measurement System2Cleared 510(K)
- K170600CARTO 3 EP Navigation System, Version 6.0 and Accessories2Cleared 510(K)
- K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable2Cleared 510(K)
- K162023CardioDay V2.52Cleared 510(K)
- K162793RHYTHMIA HDx Mapping System2Cleared 510(K)
- K162643MediGuide Technology System2Cleared 510(K)
- K160218AutoMark Module2Cleared 510(K)
- K160210EnSite Precision Cardiac Mapping System v2.02Cleared 510(K)
- K162440CardioInsight Cardiac Mapping System2Cleared 510(K)
- K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.02Cleared 510(K)
- K160186EnSite Velocity Surface Electrode Kit2Cleared 510(K)
- K153654Sentry WEB SmartInterp2Cleared 510(K)
- K161465CardioConfirm2Cleared 510(K)
- K161240Rhythm View Workstation (non-streaming)2Cleared 510(K)
- K161245EP-TRACER System2Cleared 510(K)
- K152864Merge Hemo2Cleared 510(K)
- K152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM2Cleared 510(K)
- K152160Navik 3D2Cleared 510(K)
- K151787Holter System2Cleared 510(K)
- K152993MUSE Cardiology Information System2Cleared 510(K)
- K151911WorkMate Claris System, WorkMate Claris System Display Plus2Cleared 510(K)
- K151613iLab Polaris Multi-Modality Guidance System2Cleared 510(K)
- K142349TM eCloud ECG Analysis System2Cleared 510(K)
- K151245Rhythm View Workstation (non-streaming, steaming option)2Cleared 510(K)
- K150990ECVUE Mapping System2Cleared 510(K)
- K150493Sensis2Cleared 510(K)
- K143449ADH 200 Analyzer Software2Cleared 510(K)
- K142901RhythmView Workstation2Cleared 510(K)
- K142681ZEUS (ZIO ECG Utilization Service) System2Cleared 510(K)
- K140497ECVUE MAPPING SYSTEM2Cleared 510(K)
- K133916CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.22Cleared 510(K)
- K141185V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM2Cleared 510(K)
- K141050ENSITE VELOCITY SYSTEM2Cleared 510(K)
- K133534MCKESSON CARDIOLOGY ECG MOBILE2Cleared 510(K)
- K134044EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM2Cleared 510(K)
- K132782CARTO3 EP NAVIGATION SYSTEM, VERSION 3.22Cleared 510(K)
- K133305RHYTHM VIEW WORKSTATION2Cleared 510(K)
- K132437MARS HOLTER ANALYSIS WORKSTATION2Cleared 510(K)
- K132073EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE2Cleared 510(K)
- K130727ENSITE VELOCITY SYSTEM2Cleared 510(K)
- K130516CARDIODAY2Cleared 510(K)
- K131812SENSIS, SENSIS LITE2Cleared 510(K)
- K130750RHYTHMIA MAPPING SYSTEM2Cleared 510(K)
- K131045ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE2Cleared 510(K)
- K130594ENSITE VELOCITY SYSTEM2Cleared 510(K)
- K130626MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS2Cleared 510(K)
- K123295RHYTHM VIEW2Cleared 510(K)
- K123984QUANTIEN MEASUREMENT SYSTEM2Cleared 510(K)
- K130155MUSE CARDIOLOGY INFORMATION SYSTEM2Cleared 510(K)
- K123466HEALTHVIEW ECG MANAGER2Cleared 510(K)
- K121638ST80I STRESS TEST SYSTEM2Cleared 510(K)
- K120855INTELLISPACE ECG2Cleared 510(K)
- K120550CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)2Cleared 510(K)
- K113811V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM2Cleared 510(K)
- K113515HORIZON CARDIOLOGY ECG MANAGEMENT2Cleared 510(K)
- K120301MEDIGUIDE TECHNOLOGY2Cleared 510(K)
- K112688ENSITE VELOCITY SYSTEM V.3.02Cleared 510(K)
- K111200MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM2Cleared 510(K)
- K112007CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.22Cleared 510(K)
- K110878RHYTHMVIEW (TM)2Cleared 510(K)
- K110001SPACELABS PATHFINDER SL HOLTER ANALYZER2Cleared 510(K)
- K110132MUSE CARDIOLOGY INFORMATION SYSTEM2Cleared 510(K)
- K1107464D LV-ANALYSIS 3.02Cleared 510(K)
- K110549ENSITE VELOCITY SYSTEM2Cleared 510(K)
- K110779SPACELABS SMART DISCLOSURE SYSTEM2Cleared 510(K)
- K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM2Cleared 510(K)
- K1037824D MV-ASSESSMENT 2.02Cleared 510(K)
- K103746CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)2Cleared 510(K)
- K102905GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)2Cleared 510(K)
- K101331LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE2Cleared 510(K)
- K101328ENSITE VELOCITY SYSTEM2Cleared 510(K)
- K101667ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)2Cleared 510(K)
- K093566CARTO XP EP NAVIGATION SYSTEM, VERSION 102Cleared 510(K)
- K101419ENSITE VELOCITY SYSTEM, MODEL EE30002Cleared 510(K)
- K100362CAMBRIDGE HEART OEM2Cleared 510(K)
- K093942ENSITE VELOCITY SYSTEM V1.32Cleared 510(K)
- K093092ODYSSEY WORKSTATION2Cleared 510(K)
- K093141MARS HOLTER ANALYSIS WORKSTATION2Cleared 510(K)
- K093583EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE2Cleared 510(K)
- K093455CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES2Cleared 510(K)
- K091781GUIDED MEDICAL POSITIONING SYSTEM (GMPS)2Cleared 510(K)
- K090017CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES2Cleared 510(K)
- K092810EP-WORKMATE SYSTEM, VERSION 4.22Cleared 510(K)
- K092105RADIANALYZER XPRESS2Cleared 510(K)
- K091789CARTO RMT EP NAVIGATION SYSTEM V82Cleared 510(K)
- K091165HORIZON XVU2Cleared 510(K)
- K091075ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM2Cleared 510(K)
- K083328ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN00102Cleared 510(K)
- K083639MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE2Cleared 510(K)
- K082421HEARTSUITE HEMODYNAMICS 7.102Cleared 510(K)
- K072752BP LIMBO XL, BPTANGO XL, BP SALSA XL2Cleared 510(K)
- K082467ENSITE FUSION DYNAMIC REGISTRATION TOOL2Cleared 510(K)
- K081484HORIZON XVU2Cleared 510(K)
- K071818ENSITE FUSION DYNAMIC REGISTRATION TOOL2Cleared 510(K)
- K072502MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM2Cleared 510(K)
- K072202CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)2Cleared 510(K)
- K072919VENDYS, MODEL 6000 B B/C2Cleared 510(K)
- K071911CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR2Cleared 510(K)
- K071348EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM2Cleared 510(K)
- K060980VENDYS MODEL 5000 B/BC2Cleared 510(K)
- K070240CARTO XP EP NAVIGATION SYSTEM, VERSION 92Cleared 510(K)
- K070902MODIFICATION TO: ENSITE SYSTEM, MODEL, EE30002Cleared 510(K)
- K070254HORIZON SE2Cleared 510(K)
- K070706EP-WORKMATE2Cleared 510(K)
- K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 918102Cleared 510(K)
- K070280CARDIODAY, VERSION 2.02Cleared 510(K)
- K063277MAPMATE2Cleared 510(K)
- K061905HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.02Cleared 510(K)
- K063113EP-WORKMATE2Cleared 510(K)
- K061741MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM2Cleared 510(K)
- K060954MODIFICATION TO ENSITE SYSTEM, MODEL EE30002Cleared 510(K)
- K053194NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE2Cleared 510(K)
- K051907INNOCOR2Cleared 510(K)
- K052976DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES2Cleared 510(K)
- K053369MEDILOG DARWIN HOLTER ANALYSIS2Cleared 510(K)
- K052977DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES2Cleared 510(K)
- K052883CARDIOSERVER2Cleared 510(K)
- K042681CARTO RMT EP NAVIGATION SYSTEM2Cleared 510(K)
- K051026MARS HOLTER ANALYSIS WORKSTATION2Cleared 510(K)
- K051471CARDIODAY2Cleared 510(K)
- K050093MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM2Cleared 510(K)
- K050561WINDSURFER2Cleared 510(K)
- K043604LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE2Cleared 510(K)
- K050225HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM2Cleared 510(K)
- K050614MUSE CARDIOLOGY INFORMATION SYSTEM2Cleared 510(K)
- K042999CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 82Cleared 510(K)
- K043564HORIZON ANGIO CATHLAB2Cleared 510(K)
- K041031CARDIOSTATION-100 (CS-100)2Cleared 510(K)
- K042628MODIFICATION TO: RADIANALYZER, MODEL 127112Cleared 510(K)
- K042849CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)2Cleared 510(K)
- K033266VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS2Cleared 510(K)
- K042148HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES2Cleared 510(K)
- K042799QRS-CARD CARDIOLOGY SUITE2Cleared 510(K)
- K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER2Cleared 510(K)
- K042493ENSITE SYSTEM, MODEL EE30002Cleared 510(K)
- K042463HOLTER PLUS2Cleared 510(K)
- K032519ENDO PAT 20002Cleared 510(K)
- K033211ENSITE SYSTEM2Cleared 510(K)
- K032513T-WAVE ALTERNANS (TWA) ALGORITHM OPTION2Cleared 510(K)
- K032577MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM2Cleared 510(K)
- K030145GALIX WINTER2Cleared 510(K)
- K031970INFINITY MEGACARE2Cleared 510(K)
- K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 926012Cleared 510(K)
- K032225EP-WORKMATE WITH RPM SYSTEM2Cleared 510(K)
- K031561CARDIOSOFT/CASE CARDIAC TESTING SYSTEM2Cleared 510(K)
- K031550REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE2Cleared 510(K)
- K031000LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.02Cleared 510(K)
- K030129MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE30002Cleared 510(K)
- K022596BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)2Cleared 510(K)
- K020863CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM2Cleared 510(K)
- K023370CHEETAH I.V.D.S., MODEL 2002P2Cleared 510(K)
- K023112PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.92Cleared 510(K)
- K023380T-WAVE ALTERMANS (TWA) ALGORITHM OPTION2Cleared 510(K)
- K020440NEWCOR2Cleared 510(K)
- K022188RADIANALYZER, MODEL 127102Cleared 510(K)
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- K001592ECHOCOM, IMAGECOM, DOKUCOM2Cleared 510(K)
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- K992479ENSITE 3000 SYSTEM2Cleared 510(K)
- K992948MAC-LAB SYSTEM2Cleared 510(K)
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- K974546BIOSENSOR HOLTER MONITOR SYSTEM2Cleared 510(K)
- K974192BIOSENSOR HOLTER MONITOR SYSTEM2Cleared 510(K)
- K970570NIVP3 (WINDOWS VERSION OF NIVP2Cleared 510(K)
- K962930SPACELABS MEDICAL ECG ANALYSIS SYSTEM2Cleared 510(K)
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- K951902PATHFINDER 700 HOLTER ANALYZER2Cleared 510(K)
- K950944AMBULATORY (HOLTER) RECORDING SYSTEM2Cleared 510(K)
- K961009STRESSWRITER EXERCISE TESTING SYSTEM2Cleared 510(K)
- K961063AS/3 CARDIAC OUTPUT & SVO2 MODULE2Cleared 510(K)
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- K942771RESPIEVENTS2Cleared 510(K)
- K942852RESPITRACE PT2Cleared 510(K)
- K950723AMBULATORY (HOLTER) RECORDING SYSTEM2Cleared 510(K)
- K945068OMEGA CARES SYSTEM2Cleared 510(K)
- K950988HOLTER 60002Cleared 510(K)
- K954395CARTO SYSTEM2Cleared 510(K)
- K952846EPICARDIA2Cleared 510(K)
- K945985PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 84002Cleared 510(K)
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- K930564HOLTER FOR WINDOWS2Cleared 510(K)
- K935043SIEMENS CLINICAL WORK STATION2Cleared 510(K)
- K941762INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)2Cleared 510(K)
- K935186ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY2Cleared 510(K)
- K942565ALTAIR-DISC RECORDER2Cleared 510(K)
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- K931900COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.2Cleared 510(K)
- K932954AVOXIMETER2Cleared 510(K)
- K930639ON-LINE ANALYSIS SYSTEM2Cleared 510(K)
- K925285DUALTHERM(R) CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K920587PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS2Cleared 510(K)
- K922171CENTRA II ANALYSIS SYSTEM2Cleared 510(K)
- K921216OFF-LINE ANALYSIS SYSTEM2Cleared 510(K)
- K920295MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)2Cleared 510(K)
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- K914105CATHWRITER(TM)2Cleared 510(K)
- K911615HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 3002Cleared 510(K)
- K913193MODEL 100 CENTRAL STATION2Cleared 510(K)
- K905248NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS2Cleared 510(K)
- K905100HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST2Cleared 510(K)
- K900814CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS2Cleared 510(K)
- K896017THE OPHTHIMUS SYSTEM2Cleared 510(K)
- K902716PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)2Cleared 510(K)
- K892113Q5000 PC WORKSTATION2Cleared 510(K)
- K883152EP-STAT2Cleared 510(K)
- K880879WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION2Cleared 510(K)
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- K874171MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM2Cleared 510(K)
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- K864583CARDIAC PERFORMANCE MONITOR2Cleared 510(K)
- K860854CRITICALC2Cleared 510(K)
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- K855055PDS 9000 PATIENT DATA MGMT. SYSTEM2Cleared 510(K)
- K851637SIRECUST 425, RESPECTIVELY SIRECUST 4302Cleared 510(K)
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- K842339COMPUSTRESS STRESS TESTING SYS2Cleared 510(K)
- K840875MULTIVARIATE DIGITAL CARDIOGRAPH2Cleared 510(K)
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- K810731MODEL IM1000 INTEGRATED MONITOR2Cleared 510(K)
- K801810PACEMAKER PATIENT MGMT. SYSTEM2Cleared 510(K)
- K800766ECHO-COMP2Cleared 510(K)
- K800092COMBISON COMPUTER2Cleared 510(K)
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- K792525IREX CARDIOPLAN2Cleared 510(K)
- K791776ARRHYTHMIA II EDITOR2Cleared 510(K)
- K782072QUINTON STATUS 10002Cleared 510(K)
- K780468CLINICAL GRAPHICS ANALYZER2Cleared 510(K)
- K780768MODEL 5621A INTERFACE2Cleared 510(K)
- K780530AUTOMATED PHYSIOLOGIC PROFILER2Cleared 510(K)
- K770705CARDIAC ACQUISITION SYSTEM, ICR 20012Cleared 510(K)
- K760767MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM2Cleared 510(K)
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- NPGCatheter, Infusion, Syringe2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K243781
- 510(k) Type
- Traditional
- Applicant
- Edwards Lifesciences
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/23/2025
- Days to Decision
- 226 days
- Submission Type
- Summary