BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Penumbra Indigo System

    Reg #: 3015615738 · FEI: 3015615738 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Penumbra Inc.
    Registration Number
    3015615738
    FEI Number
    3015615738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1070 SOUTH 3800 WEST, SUITE 500
    City
    Salt Lake City
    State
    UT
    ZIP
    84104
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160533

    Owner / Operator

    Firm Name
    PENUMBRA, INC.
    Operator Number
    9072336
    Address
    One Penumbra Place
    City
    Alameda
    State
    CA
    Postal Code
    94502
    Country
    US

    Products

    Device Name Product Code
    Peripheral Mechanical Thrombectomy With Aspiration QEW

    Proprietary Names

    Penumbra Indigo System

    Establishment Types

    Manufacture Medical Device