BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHAPE MEMORY MEDICAL INC

    Reg #: 3013353964 · FEI: 3013353964 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SHAPE MEMORY MEDICAL INC
    Registration Number
    3013353964
    FEI Number
    3013353964
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1321 Ridder Park Drive, Suite 10
    City
    San Jose
    State
    CA
    ZIP
    95131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182390

    Owner / Operator

    Firm Name
    Shape Memory Medical Inc
    Operator Number
    10055775
    Address
    1321 Ridder Park Drive, Suite 10
    City
    San Jose
    State
    CA
    Postal Code
    95131
    Country
    US
    Correspondent
    Meghan L Reu

    Products

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

    Proprietary Names

    IMPEDE-FX Embolization Plug TrelliX Embolic Coil System IMPEDE-FX RapidFill IMPEDE Embolization Plug

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only