BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intellisep Cartridge

    Reg #: 3005288662 · FEI: 3005288662 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Westec Plastics Corporation
    Registration Number
    3005288662
    FEI Number
    3005288662
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6757 Las Positas Rd Ste A
    City
    Livermore
    State
    CA
    ZIP
    94551
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220991

    Owner / Operator

    Firm Name
    QA Manager
    Operator Number
    10091936
    Address
    6757 Las Positas Rd.
    City
    Livermore
    State
    CA
    Postal Code
    94550
    Country
    US
    Correspondent
    Lucero Castro

    Products

    Device Name Product Code
    Deformability Cytometry For Sepsis Risk Assessment QUT

    Proprietary Names

    Intellisep Cartridge

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)