BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tigereye CTO-crossing catheter

    Reg #: 3007498664 · FEI: 3007498664 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AVINGER, INC.
    Registration Number
    3007498664
    FEI Number
    3007498664
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    400 Chesapeake Drive
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201330

    Owner / Operator

    Firm Name
    Avinger, Inc.
    Operator Number
    10027414
    Address
    400 Chesapeake Dr
    City
    Redwood City
    State
    CA
    Postal Code
    94063
    Country
    US
    Correspondent
    Thomas Lawson

    Products

    Device Name Product Code
    Catheter For Crossing Total Occlusions PDU
    System, Imaging, Optical Coherence Tomography (Oct) NQQ

    Proprietary Names

    Tigereye CTO-crossing catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device