BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Diamondback 360® Peripheral Orbital Atherectomy

    Reg #: 3004742232 · FEI: 3004742232 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    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
    K210586

    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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device