BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Volcano Corporation

    Reg #: 3008363989 · FEI: 3008363989 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    81
    Establishment Types
    2
    Classifications
    21

    Registration Details

    Registration Name
    Volcano Corporation
    Registration Number
    3008363989
    FEI Number
    3008363989
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3721 Valley Centre Dr Ste 500
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053174

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2939520
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Computer, Blood-Pressure DSK
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Interventional Fluoroscopic X-Ray System OWB
    Detector And Alarm, Arrhythmia DSI
    Drape, Surgical, Antimicrobial KKX
    Wire, Guide, Catheter DQX
    Transducer, Pressure, Catheter Tip DXO
    Computer, Diagnostic, Programmable DQK
    Oximeter DQA
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Ultrasound, Intravascular OBJ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Ventilator, Continuous, Facility Use CBK
    Cannula, Nasal, Oxygen CAT
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Connector, Airway (Extension) BZA
    Catheter For Crossing Total Occlusions PDU
    Catheter, Peripheral, Atherectomy MCW
    Catheter, Intravascular, Diagnostic DQO

    Proprietary Names

    LoFlo Module - RoHS - Private Label C5 LoFlo Sidestream Module Respironics Alice, LoFlo, C5 Sidestream Module Respironics LoFlo Sidestream CO2 Module s5/s5i IVUS Imaging System CORE Control Pad PIM, Patient Interface module SyncRx SyncVision System Reusable Adult/Pediatric Ear Clip SpO2 Sensor(1.5m) Reusable Pediatric/Small/Adult Finger SpO2 Sensor Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m) Volcano CORE Control Pad, Accessory to the Volcano CORE/CORE Mobile Precision Guided Therapy Systems Sterile Equipment Covers Software v3.5 Verrata Plus Pressure Guide Wire IntraSight Plus LumiGuide 3D Hub LumiGuide Equipment R2.1 LumiGuide Wire OmniWire Pressure Guide Wire 806426-008 – ComboMap Software v1.9 Document Kit 806426-012 – ComboMap Software v2.1 Upgrade Kit 803523-001 – ComboMap Cart Kit 806426-004 – ComboMap Software v1.9 Upgrade Kit 807062-001 – ComboMap Sterile Cover 803521-001, 802745-001 – ComboMap System AltaTrack Equipment R1.2 AltaTrack Guidewire AltaTrack 3D Hub Infant Disposable SpO2 Sensor Neonatal / Infant / Adult Disposable SpO2 Sensor Reconnaissance PV 18 OTW Digital IVUS Catheter Mainstream CO2 Sensor Reusable NEO Airway Adapter, Philips Reusable ADU-PED Airway Adapter, Philips Reusable Adult SpO2 Clip Sensor(0.9m) Reusable Adult SpO2 Clip Sensor(3m) CAPNOSTAT 5 Mainstream Sensor, Maquet Reusable Adult/Pediatric Airway Adapter ADULT AIRWAY ADAPTER, QTY 1, MAQUET CAPNOSTAT 5 Mainstream CO2 sensor Visions PV 18 Digital IVUS Catheter Neonatal and Pediatric CO2 Airway Adapter, Reusable Pediatric and Adult CO2 Airway Adapter, Reusable Neonatal Airway Adapter AA&TRAY ASSY, ADU, ZOLL MED 8000-0262 CAPNOSTAT 5 Mainstream Sensor - RoHS - Private label Pediatric/Adult Airway Adapter Reusable Neonatal CO2 Airway Adapter Adapter ADU Reuse Capnostat 704-0002-00 Reusable Airway Adapter MaInstream CO2 Adult Zoll Neonatal Reusable Adapter, Qty 1 LumiGuide Equipment R2 Adhesive-free Neonatal/Infant/Adult Disposable SpO2 Sensor s5i R-100 Automatic Pullback Device IntraSight Visions PV 14P RX Digital IVUS Catheter Capnostat 5 Mainstream CO2 Sensor Capnography Sensor, Reusable Refinity ST Rotational IVUS Catheter Visions PV 35 Digital IVUS Catheter CORE M2 Vascular System Software v4.2 CORE M2 Vascular System Upgrade Kit, SyncVision v4.2 Disposable Adult / Pediatric SpO2 Sensor 300000629191, Upgrade Kit, SyncVision v4.1 IntraSight Mobile System Eagle Eye Platinum ST RX Digital IVUS Catheter Eagle Eye Platinum RX Digital IVUS Catheter Visions Pioneer Plus Catheter VeriSight/VeriSight Pro ICE Catheter CORE s5/s5i Phoenix Atherectomy System 2.2mm x 149cm Phoenix Atherectomy System 1.8mm x 149cm Phoenix Atherectomy Catheter 1.8mm x 149cm Phoenix Handle with Wire Support Clip Phoenix Atherectomy Catheter 2.2mm x 149cm AltaTrack equipment R1

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility