BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Helo G1 Thrombectomy System

    Reg #: 3026567963 · FEI: 3026567963 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ENDOVASCULAR ENGINEERING, INC.
    Registration Number
    3026567963
    FEI Number
    3026567963
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3925 Bohannon Drive, Suite 300
    City
    Menlo Park
    State
    CA
    ZIP
    94025
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223891

    Owner / Operator

    Firm Name
    Endovascular Engineering, Inc.
    Operator Number
    10087452
    Address
    3925 Bohannon Drive, Suite 300
    City
    Menlo Park
    State
    CA
    Postal Code
    94025
    Country
    US
    Correspondent
    Debra Cogan

    Products

    Device Name Product Code
    Catheter, Continuous Flush KRA
    Peripheral Mechanical Thrombectomy With Aspiration QEW

    Proprietary Names

    Helo G1 Thrombectomy System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device