BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARDIOVASCULAR SYSTEMS INCORPORATED

    Reg #: 3008814558 · FEI: 3008814558 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Registration Number
    3008814558
    FEI Number
    3008814558
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14740 Kirby Dr
    City
    Houston
    State
    TX
    ZIP
    77047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190634
    PMA Number
    P130005

    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
    Catheter, Coronary, Atherectomy MCX
    Catheter, Percutaneous DQY

    Proprietary Names

    Stealth OAS Diamondback OAS Diamondback Peripheral Micro 20 Max Crown Stealth 360 PAD System Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Viperwire Advance with Flextip DIAMONDBACK 360 Peripheral Orbital Atherectomy System DIAMONDBACK 360 Coronary Orbital Atherectomy System Diamondback 360® Peripheral Orbital Atherectomy ViperCath XC Peripheral Exchange Catheter Diamondback VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy Guidewire

    Establishment Types

    Manufacture Medical Device