BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lutonix, Inc.

    Reg #: 3006513822 · FEI: 3006513822 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Lutonix, Inc.
    Registration Number
    3006513822
    FEI Number
    3006513822
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1625 West 3rd Street
    City
    Tempe
    State
    AZ
    ZIP
    85281
    Country
    US

    Regulatory Submissions

    PMA Number
    P130024

    Owner / Operator

    Firm Name
    C. R. Bard, Inc.
    Operator Number
    2212754
    Address
    1 Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

    Device Name Product Code
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Drug-Coated Peripheral Transluminal Angioplasty Catheter PRC

    Proprietary Names

    Lutonix 018 Drug Coated Balloon PTA Catheter Lutonix 035 Drug Coated Balloon PTA Catheter Lutonix Drug Coated Balloon Lutonix 014 Drug Coated Balloon PTA Catheter Lutonix 014 PTCA Drug Coated Balloon Catheter

    Establishment Types

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