BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HydroPearl Microsphere

    Reg #: 3013556777 · FEI: 3013556777 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MicroVention, Inc.
    Registration Number
    3013556777
    FEI Number
    3013556777
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    35 Enterprise
    City
    Aliso Viejo
    State
    CA
    ZIP
    92656
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192684

    Owner / Operator

    Firm Name
    MicroVention Inc.
    Operator Number
    10033879
    Address
    35 Enterprise
    City
    Aliso Viejo
    State
    CA
    Postal Code
    92656
    Country
    US
    Correspondent
    Scafford Serron

    Products

    Device Name Product Code
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Device, Vascular, For Promoting Embolization KRD
    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY

    Proprietary Names

    HydroPearl Microsphere

    Establishment Types

    Manufacture Medical Device