BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Volcano Corporation by Volcarica S.R.L.

    Reg #: 3009490946 · FEI: 3009490946 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    Volcano Corporation by Volcarica S.R.L.
    Registration Number
    3009490946
    FEI Number
    3009490946
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Coyol Free Zone and Business Park, Building B37
    City
    Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K202543

    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

    US Agent

    Business Name
    Philips
    Contact Name
    Megan Olen
    Address
    9965 Federal Drive
    City
    Colorado Springs
    State
    CO
    ZIP
    80921
    Country
    US
    Email
    [email protected]
    Phone
    719 4472592

    Products

    Device Name Product Code
    Transducer, Pressure, Catheter Tip DXO
    Wire, Guide, Catheter DQX
    Oximeter DQA
    Catheter, Ultrasound, Intravascular OBJ
    Transducer, Ultrasonic, Diagnostic ITX
    Cannula, Nasal, Oxygen CAT
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Detector And Alarm, Arrhythmia DSI
    Ventilator, Continuous, Facility Use CBK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Connector, Airway (Extension) BZA

    Proprietary Names

    OmniWire Pressure Guide Wire Adhesive-free Neonatal/Infant/Adult Disposable SpO2 Sensor Eagle Eye Platinum ST RX Digital IVUS Catheter Eagle Eye Platinum RX Digital IVUS Catheter Reusable Adult SpO2 Clip Sensor(0.9m) Reusable Adult SpO2 Clip Sensor(3m) Reconnaissance PV 18 OTW Digital IVUS Catheter Visions PV 18 Digital IVUS Catheter Neonatal and Pediatric CO2 Airway Adapter, Reusable Pediatric and Adult CO2 Airway Adapter, Reusable Mainstream CO2 Sensor Reusable NEO Airway Adapter, Philips Reusable ADU-PED Airway Adapter, Philips Reusable Adult/Pediatric Ear Clip SpO2 Sensor(1.5m) Reusable Pediatric/Small/Adult Finger SpO2 Sensor Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m) Infant Disposable SpO2 Sensor Neonatal / Infant / Adult Disposable SpO2 Sensor Reusable Adult/Pediatric Airway Adapter ADULT AIRWAY ADAPTER, QTY 1, MAQUET Capnostat 5 Mainstream CO2 Sensor Capnography Sensor, Reusable LoFlo Module - RoHS - Private Label C5 LoFlo Sidestream Module Respironics Alice, LoFlo, C5 Sidestream Module Respironics LoFlo Sidestream CO2 Module Refinity ST Rotational IVUS Catheter CAPNOSTAT 5 Mainstream CO2 sensor Disposable Adult / Pediatric SpO2 Sensor Visions PV 14P RX Digital IVUS Catheter Visions PV 35 Digital IVUS Catheter 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 CAPNOSTAT 5 Mainstream Sensor, Maquet VeriSight/VeriSight Pro ICE Catheter

    Establishment Types

    Manufacture Medical Device