BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Refinity ST Rotational IVUS Catheter

    Reg #: 3009490946 · FEI: 3009490946 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Volcano Corporation by Volcarica S.R.L.
    Registration Number
    3009490946
    FEI Number
    3009490946
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Coyol Free Zone and Business Park, Building B37
    City
    Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K160583

    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, Ultrasonic, Diagnostic ITX
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    Refinity ST Rotational IVUS Catheter

    Establishment Types

    Manufacture Medical Device