Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- DSMAlarm, Leakage Current, Portable1Product Code
- DPSElectrocardiograph2Product Code
- DPTProbe, Blood-Flow, Extravascular2Product Code
- DPWFlowmeter, Blood, Cardiovascular2Product Code
- DQBPhlebograph, Impedance2Product Code
- DQCPhonocardiograph1Product Code
- DQHCardiograph, Apex (Vibrocardiograph)2Product Code
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2Product Code
- DRIMonitor, Line Isolation1Product Code
- DRJSystem, Signal Isolation1Product Code
- DRQAmplifier And Signal Conditioner, Transducer Signal2Product Code
- DRRAmplifier And Signal Conditioner, Biopotential2Product Code
- DRSTransducer, Blood-Pressure, Extravascular2Product Code
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)2Product Code
- DRWAdaptor, Lead Switching, Electrocardiograph2Product Code
- DRXElectrode, Electrocardiograph2Product Code
- DRZOscillometer2Product Code
- DSACable, Transducer And Electrode, Patient, (Including Connector)2Product Code
- K251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter2Cleared 510(K)
- K242986SpO2 Extension Cable2Cleared 510(K)
- K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn2Cleared 510(K)
- K240087RT Carbon ECG Leads2Cleared 510(K)
- K240377LIFEPAK® ECG Cables2Cleared 510(K)
- K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)2Cleared 510(K)
- K222712Fogg System Patient Monitoring Cables2Cleared 510(K)
- K230571RFP-100A Connector Cable (Single Use)2Cleared 510(K)
- K222370SpO2 Extension Cable2Cleared 510(K)
- K220447Med-link Disposable ECG Cable and Leadwires2Cleared 510(K)
- K2119419Line2Cleared 510(K)
- K211294Multi-Link X2 ECG Cable and Leadwire System2Cleared 510(K)
- K203556Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables2Cleared 510(K)
- K200722PCA-C1 series Patient Cable2Cleared 510(K)
- K203635Patient Monitoring Cables2Cleared 510(K)
- K200510Multi-LinkTM X2 ECG Adapter and Leadwires2Cleared 510(K)
- K201359ECG Cables and Leadwires2Cleared 510(K)
- K200674AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector2Cleared 510(K)
- K192404Patient Monitoring Cable (SpO2 Extension Cable)2Cleared 510(K)
- K200026Disposable ECG Cable2Cleared 510(K)
- K181089SureLead Cable System2Cleared 510(K)
- K191428ECG Cable2Cleared 510(K)
- K191273Multi-Link X2 ECG and SpO2 Adapter2Cleared 510(K)
- K190078IntraSight2Cleared 510(K)
- K182327Patient Cables and Leadwires , Disposable ECG Leadwires2Cleared 510(K)
- K182220Curbell branded Patient Monitoring Cables2Cleared 510(K)
- K181726Medline Patient Cables and Lead Wires2Cleared 510(K)
- K172797ECG Cable/Leadwires2Cleared 510(K)
- K172591Fixed Patient Leads ECG Cable (Model 3153)2Cleared 510(K)
- K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables2Cleared 510(K)
- K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System2Cleared 510(K)
- K170536ECG Disposable Lead Wire2Cleared 510(K)
- K162432Multi-Link X2 ECG Cable and Lead Wire System2Cleared 510(K)
- K153188Caremed patient cable and leadwires2Cleared 510(K)
- K152947Disposable Temporary Pacing Cable2Cleared 510(K)
- K142489Unimed Disposable ECG lead wires2Cleared 510(K)
- K132253REMOVABLE PATIENT LEADS ECG CABLE2Cleared 510(K)
- K120010CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)2Cleared 510(K)
- K110287PHILIPS ECG LEADWIRE SET2Cleared 510(K)
- K102430TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET2Cleared 510(K)
- K101660ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-82Cleared 510(K)
- K093858PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A2Cleared 510(K)
- K093657ADAGIO RETRACTING ECG LEAD WIRES2Cleared 510(K)
- K082851MULTLINK CABLE AND LEADWIRE SYSTEM2Cleared 510(K)
- K082959PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS2Cleared 510(K)
- K081762CURBELL PATIENT MONITORING CABLES2Cleared 510(K)
- K080112PATIENT CABLE2Cleared 510(K)
- K080605SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL2Cleared 510(K)
- K080621FASTLOCK, MODEL PC175M01, PC175MCE, PC005R012Cleared 510(K)
- K071751LIFESYNC ADAPTER, MODEL LS-3022Cleared 510(K)
- K070232ECG CABLES, TRUNK AND PATIENT LEAD WIRES2Cleared 510(K)
- K062577V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC2Cleared 510(K)
- K043572COMPATIBILITY ECG TRUNK CABLES2Cleared 510(K)
- K030005VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES2Cleared 510(K)
- K023334BMC CATHETER CONNECTOR CABLE, MODEL RFP-1012Cleared 510(K)
- K022075DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-52Cleared 510(K)
- K013598REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES2Cleared 510(K)
- K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 42602Cleared 510(K)
- K010809BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 400002Cleared 510(K)
- K002781MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS2Cleared 510(K)
- K001390BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES2Cleared 510(K)
- K992524PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES2Cleared 510(K)
- K984263EWC: ECG II CABLE LEADWIRE SYSTEM2Cleared 510(K)
- K982817EWC: ECG CABLE AND LEADWIRE SYSTEMS2Cleared 510(K)
- K980806AFFINITY MEDICAL PATIENT CABLE SYSTEM2Cleared 510(K)
- K980582MULTI-LINK CABLE AND LEAD WIRE SYSTEMS2Cleared 510(K)
- K971968SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)2Cleared 510(K)
- K9549003M RED DOT ECG LEAD WIRES A2Cleared 510(K)
- K960446MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES2Cleared 510(K)
- K952659TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM2Cleared 510(K)
- K940323ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM2Cleared 510(K)
- K940302ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM2Cleared 510(K)
- K940322ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE2Cleared 510(K)
- K942321VARIOUSPATIENT MONITORING CABLE2Cleared 510(K)
- K945034CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES2Cleared 510(K)
- K941839DISPOSABLE SURGICAL CABLE2Cleared 510(K)
- K941058PROCATH PACING THRESHOLD CABLE2Cleared 510(K)
- K933649CONMED ECG PATIENT CABLES AND LEADWIRES2Cleared 510(K)
- K933603LEADWIRE2Cleared 510(K)
- K932704PATIENT CABLE2Cleared 510(K)
- K922009DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-1012Cleared 510(K)
- K922899MODEL 4280 SURGICAL EXTENSION CABLE2Cleared 510(K)
- K910645DISPOSABLE PATIENT CABLE2Cleared 510(K)
- K901780RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE2Cleared 510(K)
- K894981MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE2Cleared 510(K)
- K885137ASTRO TRACE (MODEL AT-02)2Cleared 510(K)
- K884592ASTRO TRACE (MODEL AT-01)2Cleared 510(K)
- K885101MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR2Cleared 510(K)
- K882174MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE2Cleared 510(K)
- K880323MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR2Cleared 510(K)
- K880320ELECTRODE CABLE2Cleared 510(K)
- K873492BSK-1033 TELEMETRY MONITORING CABLE2Cleared 510(K)
- K820268ADAPTAID TEMP. PACING EXT. LEAD #366-022Cleared 510(K)
- K802236CORROSION PROOF SNAP ECG CONNECT WIRES2Cleared 510(K)
- K802237CORROSION PROOF DUAL PURPOSE ECG WIRES2Cleared 510(K)
- K8010413M R.F. CURRENT SUPPRESSOR2Cleared 510(K)
- K800931R2(TM) ECG CABLE-ADAPTOR #'S 120-121-1222Cleared 510(K)
- K800932ECG-RF-CHOKE CABLE-ADAPTER #'S 121,1202Cleared 510(K)
- K801064DISPOSABLE PATIENT CABLE MODEL 58072Cleared 510(K)
- K771645ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE2Cleared 510(K)
- K771750RF CHOKE CABLE2Cleared 510(K)
- K771027ELECTROCARDIOGRAPHIC PATIENT CABLES2Cleared 510(K)
- K770884ELHCTROCARDIOGRAPHIC CONNECTING WIRES2Cleared 510(K)
- DSBPlethysmograph, Impedance2Product Code
- DSFRecorder, Paper Chart1Product Code
- DSHRecorder, Magnetic Tape, Medical2Product Code
- DXHTransmitters And Receivers, Electrocardiograph, Telephone2Product Code
- DXJDisplay, Cathode-Ray Tube, Medical2Product Code
- DXKEchocardiograph2Product Code
- DXOTransducer, Pressure, Catheter Tip2Product Code
- DXPTransducer, Vessel Occlusion2Product Code
- DXRBallistocardiograph2Product Code
- DYCVectorcardiograph2Product Code
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic2Product Code
- JONTransducer, Apex Cardiographic2Product Code
- JOOTransducer, Heart Sound2Product Code
- JOPTransducer, Ultrasonic2Product Code
- KRCTester, Electrode, Surface, Electrocardiographic2Product Code
- MLCMonitor, St Segment2Product Code
- MLNElectrode, Electrocardiograph, Multi-Function2Product Code
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2Product Code
- MSXSystem, Network And Communication, Physiological Monitors2Product Code
- MUDOximeter, Tissue Saturation2Product Code
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2Product Code
- MWJElectrocardiograph, Ambulatory (Without Analysis)2Product Code
- MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)2Product Code
- NMDOximeter, Tissue Saturation, Reprocessed2Product Code
- NQHSensor, Pressure, Aneurysm, Implantable2Product Code
- OCHOximeter, Infrared, Sporting, Aviation2Product Code
- OEYSingle Lead Over-The-Counter Electrocardiograph2Product Code
- QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate2Product Code
- OFILaser Blood Flow Kit2Product Code
- PFYLow Patient Acuity Monitoring System2Product Code
- PLBMultivariate Vital Signs Index2Product Code
- PPWAdjunctive Cardiovascular Status Indicator2Product Code
- QAQAdjunctive Predictive Cardiovascular Indicator2Product Code
- QDAElectrocardiograph Software For Over-The-Counter Use2Product Code
- QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use2Product Code
- QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator2Product Code
- QNVAdjunctive Hemodynamic Indicator With Decision Point2Product Code
- QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate2Product Code
- QUOAdjunctive Heart Failure Status Indicator2Product Code
- QXZAdjunctive Epicardial Vascular Physiologic Status Indicator2Product Code
- SARAdjunctive Hemodynamic Indicator With Decision Point For Military Use2Product Code
- SDJAdjunctive Cardiac Amyloidosis Status Indicator2Product Code
- SDYLoss Of Pulse Notification Software2Product Code
- 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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IntraSight
- Page Type
- Cleared 510(K)
- 510(k) Number
- K190078
- 510(k) Type
- Special
- Applicant
- Volcano Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/11/2019
- Days to Decision
- 26 days
- Submission Type
- Summary