BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stentra

    Reg #: 3030254046 · FEI: 3030254046 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    KALLISIO INC.
    Registration Number
    3030254046
    FEI Number
    3030254046
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1734 Maryland Avenue
    City
    Baltimore
    State
    MD
    ZIP
    21201
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232293

    Owner / Operator

    Firm Name
    kallisio Inc.
    Operator Number
    10089706
    Address
    1734 Maryland Avenue
    City
    Baltimore
    State
    MD
    Postal Code
    21201
    Country
    US
    Correspondent
    Rajan Patel

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Stentra

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility