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
- 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
- K251275VitalStream ART Connect; VitalStream-Hemo2Cleared 510(K)
- K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMS2Cleared 510(K)
- K212529Hypotension Decision Assist Model HDA-OR22Cleared 510(K)
- K192169PulsioFlex Monitoring System with ProAQT Sensor2Cleared 510(K)
- K193179EV1000 Clinical Platform2Cleared 510(K)
- K190955Hypotension Decision Assist2Cleared 510(K)
- K181372Argos2Cleared 510(K)
- K172259PulsioFlex Monitoring System2Cleared 510(K)
- K163334LiDCOunity v2 Hemodynamic Monitor2Cleared 510(K)
- K152935LiDCOunity Monitor2Cleared 510(K)
- K134051TRANSONIC ELSA SYSTEM2Cleared 510(K)
- K134035TRANSONIC HCM 103 SYSTEM2Cleared 510(K)
- K140017TRANSONIC HCM 102 SYSTEM2Cleared 510(K)
- K132892TEBCO-W2Cleared 510(K)
- K131892EV1000 CLINICAL PLATFORM2Cleared 510(K)
- K131588VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR2Cleared 510(K)
- K132528E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES2Cleared 510(K)
- K122400CARDIOX FLOW DETECTION SYSTEM2Cleared 510(K)
- K131048LIDCO CNAP MODULE2Cleared 510(K)
- K122247LIDCORAPID V2 MONITOR2Cleared 510(K)
- K113821TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM2Cleared 510(K)
- K122121PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE2Cleared 510(K)
- K112448PULSIOFLEX2Cleared 510(K)
- K110597EV1000 CLINICAL PLATFORM2Cleared 510(K)
- K103094VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR2Cleared 510(K)
- K100709EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M2Cleared 510(K)
- K101487CHEETAH NICOM SYSTEM2Cleared 510(K)
- K091786PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)2Cleared 510(K)
- K092219NAVIGATOR CLINICAL GUIDENCE SYSTEM2Cleared 510(K)
- K082308MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR2Cleared 510(K)
- K080116TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM2Cleared 510(K)
- K081776CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM2Cleared 510(K)
- K071631NICOM ELECTRODES2Cleared 510(K)
- K073113INFINITY PICCO POD, MODEL MS167342Cleared 510(K)
- K072735PULSION PICCO-2, MODEL 85002Cleared 510(K)
- K062134VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR2Cleared 510(K)
- K060898PULSION PICCO PLUS, MODEL 81002Cleared 510(K)
- K060660EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER2Cleared 510(K)
- K043103VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG22Cleared 510(K)
- K042144NICOM2Cleared 510(K)
- K040287VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR2Cleared 510(K)
- K032997MODIFICATION TO: HORIZON 9000WS2Cleared 510(K)
- K023960LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 702Cleared 510(K)
- K021874ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 567112Cleared 510(K)
- K010049PULSECO HEMODYNAMIC MONITOR CM712Cleared 510(K)
- K000664VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS2Cleared 510(K)
- K001762PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM2Cleared 510(K)
- K991775MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS2Cleared 510(K)
- K962918LIDCO SYSTEM2Cleared 510(K)
- K970784ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)2Cleared 510(K)
- K961661OXIMETRIX 4 COMPUTER SYSTEM2Cleared 510(K)
- K962128TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)2Cleared 510(K)
- K955417VITAL PAK2Cleared 510(K)
- K946115EK-VIEW(TM) ECG MANAGEMENT SYSTEM2Cleared 510(K)
- K940415HORIZON 9000 WS2Cleared 510(K)
- K943256CARDIAC OUTPUT OPTION 392Cleared 510(K)
- K932414CONTINUOUS CARDIAC OUTPUT SYSTEM2Cleared 510(K)
- K922218IQ SYSTEM2Cleared 510(K)
- K913358MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST2Cleared 510(K)
- K902628INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT2Cleared 510(K)
- K896930CARDIAC OUTPUT COMPUTER, MODEL COM-32Cleared 510(K)
- K901926SORBA MODEL CIC-1000 W/NEW ELECTRODES2Cleared 510(K)
- K895017SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH2Cleared 510(K)
- K897004NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM2Cleared 510(K)
- K896528SFA MODULE2Cleared 510(K)
- K894234SENSOCOR TM R-TEST 24OXL2Cleared 510(K)
- K893392CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K884122TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA2Cleared 510(K)
- K884619PACH-PEN CALCULATOR2Cleared 510(K)
- K883855PREDICTOR II SIGNAL AVERAGING ECG2Cleared 510(K)
- K8803013000 PHYSIOLOGICAL MONITOR2Cleared 510(K)
- K880258WITT BIOMEDICAL VX-802Cleared 510(K)
- K880696MX1002 CABLE-CAL TM2Cleared 510(K)
- K875167HORIZON 90002Cleared 510(K)
- K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-22Cleared 510(K)
- K870375MODEL 617 CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K871659IMS-2000S STRESS MONITOR2Cleared 510(K)
- K870934IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM2Cleared 510(K)
- K865101SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM2Cleared 510(K)
- K861505HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER2Cleared 510(K)
- K861543CARDIOMAX-II2Cleared 510(K)
- K862808BIOMA 20002Cleared 510(K)
- K862261KONTRON SUPERMON CARDIAC OUTPUT MODULE 72632Cleared 510(K)
- K854371MTC 6210A CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K863153MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH2Cleared 510(K)
- K8633082200I PHYSIOLOGICAL MONITOR2Cleared 510(K)
- K863231D100 COMPUTER CARDIAC ANALYSIS SYSTEM2Cleared 510(K)
- K863230D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM2Cleared 510(K)
- K861092MODEL SP1465 CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K861437QMED SYSTEM 21502Cleared 510(K)
- K860015MODIFIED CHERNE CAD DETECTOR2Cleared 510(K)
- K853018MODEL 3000 OPTICATH COMPUTER2Cleared 510(K)
- K854136ARRHYTHMIA REVIEW STATION2Cleared 510(K)
- K852900CVERNE CAD DETECTOR2Cleared 510(K)
- K841967DESERET THERMODILUTION CARDIAC OUTPUT2Cleared 510(K)
- K834059FUKUDA DENSHI EH-112Cleared 510(K)
- K844116CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC2Cleared 510(K)
- K850568MODEL 78231D CARDIAC OUTPUT MODULE2Cleared 510(K)
- K844997IAI PROGRAM-COMPUTER PROGRAM2Cleared 510(K)
- K844682ELECATH CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K844277OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR2Cleared 510(K)
- K844665COMPUTER2Cleared 510(K)
- K843555CARDIAC COMPUTER SP14452Cleared 510(K)
- K842105RIGHT VENTRICULAR EJECTION FRACTION-2Cleared 510(K)
- K841401SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K842706SCATAID2Cleared 510(K)
- K844022ELECATH VENTRICULAR PACING THERMAL DILUTION CATH2Cleared 510(K)
- K840439RECOMED CARDIAC OUTPUT METER 236067-2Cleared 510(K)
- K841256MODELS 78551A 78552A2Cleared 510(K)
- K842831BAIM CORONARY SINUS FLOW CALCULATOR2Cleared 510(K)
- K834408TX-2 THERMAL DILUTION CARDIAC OUTPUT2Cleared 510(K)
- K840009NOVA 12 CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K841261COMPUTER, CENTRAL PROCESSING UNIT2Cleared 510(K)
- K833756SYSTEM 50002Cleared 510(K)
- K833914CARDIAC OUTPUT SIGNAL ACQUISTION2Cleared 510(K)
- K833913HEMODYNAMIC PLUG-IN MODULE 78551A2Cleared 510(K)
- K832644ALPHA CARDIAC OUTPUT CARDULE #18992Cleared 510(K)
- K833395SENTINEL SYSTEMS2Cleared 510(K)
- K831967CRITIKON CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K831057VIDEO-DILUTION TECH. MARK I INSTRUMENT2Cleared 510(K)
- K831407CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K830892THERMODILUTION CARDIAC OUTPUT COMPUTER-2Cleared 510(K)
- K830628REAL-TIME SPECTRUM ANALYZER2Cleared 510(K)
- K830003MICRO FITNESS COMPUTER2Cleared 510(K)
- K822972IL 801 THERMALDILUTION CARDIAC OUTPUT2Cleared 510(K)
- K822903AUTOECHO2Cleared 510(K)
- K822877MODEL 78554A DATA MGMT. PLUG-IN MODULE2Cleared 510(K)
- K822093STAT-SCAN2Cleared 510(K)
- K820194CARDIAC CATHERIZATION LAB MICROPROCESS2Cleared 510(K)
- K820820CARDIO REVUE CENTER2Cleared 510(K)
- K820898VASCULAB SPECTRUM ANALYZER #SP252Cleared 510(K)
- K813223DISPOSABLE PLASTIC SYRINGE W/NEEDLE2Cleared 510(K)
- K813222MODEL 4200 ELLESTAD STRESS TEST ANALYZER2Cleared 510(K)
- K812971CARDIOINTEGRAM2Cleared 510(K)
- K813020BOMED-NCCOM2Cleared 510(K)
- K812932ANERIOD GAUZE2Cleared 510(K)
- K812638DIAGNOSTIC MEDICAL COMPUTER2Cleared 510(K)
- K812757SORENSON THERMODILUTION CARDIAC COMPUT2Cleared 510(K)
- K812515CARDIAC REVIEW STATION2Cleared 510(K)
- K811560AUTOMATED PHYSIOLOGIC PROFILE MONITOR2Cleared 510(K)
- K811414BAIM CORONARY SINUS FLOW ANALYZER2Cleared 510(K)
- K811062CAMPBRIDGE COMPUTRACE2Cleared 510(K)
- K810851SPECTRUM ANALYZER 80002Cleared 510(K)
- K810163AM 420 MICROPROCESSOR2Cleared 510(K)
- K810177PATIENT MONITOR MODEL CM130, 1402Cleared 510(K)
- K810170TREND GRAPH FUNCTION BLOCK2Cleared 510(K)
- K802316PDS THERMAL DILUTION CARDIAC MODULE(OUT)2Cleared 510(K)
- K802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYS2Cleared 510(K)
- K802476CARDIACINDEX COMPUTER MODEL SP 14352Cleared 510(K)
- K802305MLC-4200 CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K802198BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM2Cleared 510(K)
- K792678CARDIAC OUTPUT COMPUTER, M-MLC-41002Cleared 510(K)
- K792080MODEL 656 ARRHYTHMIA ANALYZER2Cleared 510(K)
- K791756VDC2Cleared 510(K)
- K791753IPAG MICRONOVA INTERFACE #7811112Cleared 510(K)
- K790288STORAGE, DIGITAL DSC-1, CONTROL UNIT2Cleared 510(K)
- K790047CARDIAC OUTPUT COMPUTER, MDEL 9520A2Cleared 510(K)
- K781805CARDIAC COMPUTERS, CO-10 & CO-10R2Cleared 510(K)
- K781855LVV OPTION2Cleared 510(K)
- K781535AC ADAPTER:MODELS 9525,9526,95272Cleared 510(K)
- K772152CENTRAL MONITORING SYSTEM2Cleared 510(K)
- K771924HEARTBEATER2Cleared 510(K)
- K772158LIGHT-PEN SYSTEM FOR QUANTI. ANALY.2Cleared 510(K)
- K771991CARDIAC OUTPUT THERMODILUTION MODULE2Cleared 510(K)
- K771666SPHYGMOMANOMETER #12352Cleared 510(K)
- K771718CARDIOTHERM-500X2Cleared 510(K)
- K770675COMPUTER, CARDIAC OUTPUT, MODEL KM2752Cleared 510(K)
- K770179CARDIAC CATHETERIZATION LAB MONITOR SYS2Cleared 510(K)
- K770330MONITOR, PULSE WAVE VELOCITY P6072Cleared 510(K)
- K761166TC-1 CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K760844CARDIAC OUTPUT COMPUTER (MODEL COC-100)2Cleared 510(K)
- K760756BATTERY OPERATED FLOW RATE COMPUTER2Cleared 510(K)
- K760600CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K760774TIME-SHARING MULTIPLEXER (MODEL 78308A)2Cleared 510(K)
- K760532COMPUTER, CARDIAC OUTPUT (#SP1425)2Cleared 510(K)
- K760192COMPUTER, THERMODILUTION CARDIAC (9520)2Cleared 510(K)
- 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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PULSIOFLEX
- Page Type
- Cleared 510(K)
- 510(k) Number
- K112448
- 510(k) Type
- Special
- Applicant
- PULSION MEDICAL SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/22/2011
- Days to Decision
- 28 days
- Submission Type
- Statement