BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

    Reg #: 3004742232 · FEI: 3004742232 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Cardiovascular Systems Incorporated
    Registration Number
    3004742232
    FEI Number
    3004742232
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1225 Old Highway 8 NW
    City
    Saint Paul
    State
    MN
    ZIP
    55112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182397

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

    Establishment Types

    Manufacture Medical Device