BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Embolization Inc

    Reg #: 3042953152 · FEI: 3042953152 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Embolization Inc
    Registration Number
    3042953152
    FEI Number
    3042953152
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5421 Western Ave
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250276

    Owner / Operator

    Firm Name
    Boulder iQ
    Operator Number
    10094690
    Address
    5421 Western Ave
    City
    Boulder
    State
    CO
    Postal Code
    80301
    Country
    US
    Correspondent
    Melissa Brookshier

    Products

    Device Name Product Code
    Device, Vascular, For Promoting Embolization KRD

    Proprietary Names

    Nitinol Enhanced Device (NED)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device