BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Okami Medical Inc.

    Reg #: 3016444913 · FEI: 3016444913 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Okami Medical Inc.
    Registration Number
    3016444913
    FEI Number
    3016444913
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8 Argonaut, Suite 100
    City
    Aliso Viejo
    State
    CA
    ZIP
    92656
    Country
    US

    Regulatory Submissions

    510(k) Number
    K260508

    Owner / Operator

    Firm Name
    Okami Medical Inc.
    Operator Number
    10061852
    Address
    8 Argonaut, Suite 100, Suite 100
    City
    Aliso Viejo
    State
    CA
    Postal Code
    92656
    Country
    US

    Products

    Device Name Product Code
    Device, Vascular, For Promoting Embolization KRD
    Catheter, Percutaneous DQY

    Proprietary Names

    LOBO Vascular Occlusion System (LOBO-3-LP) LOBO Vascular Occluder (LOBO-7) LOBO Vascular Occluder (LOBO-9) LOBO Handpiece (LOBO-HP) SENDERO MAX Delivery Catheter (SENDERO-MAX55-110MP) LOBO Vascular Occluder (LOBO-5) SENDERO Microcatheter (2.9F) LOBO Vascular Occluder (LOBO-3)

    Establishment Types

    Manufacture Medical Device