BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rotarex Atherectomy System

    Reg #: 2020394 · FEI: 2020394 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BARD PERIPHERAL VASCULAR, INC.
    Registration Number
    2020394
    FEI Number
    2020394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1625 W 3rd St
    City
    TEMPE
    State
    AZ
    ZIP
    85281
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211738

    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
    Wire, Guide, Catheter DQX
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    Rotarex Atherectomy System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198