BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SpectraWAVE Imaging Catheter

    Reg #: 3017654247 · FEI: 3017654247 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPECTRAWAVE, INC.
    Registration Number
    3017654247
    FEI Number
    3017654247
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12 Oak Park Drive
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US

    Owner / Operator

    Firm Name
    SpectraWAVE, Inc.
    Operator Number
    10084575
    Address
    12 Oak Park Drive
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US

    Products

    Device Name Product Code
    Optical Coherence Tomography, Intravascular Catheter ORD

    Proprietary Names

    SpectraWAVE Imaging Catheter

    Establishment Types

    Manufacture Device in the United States for Export Only