BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CVX-300 Excimer Laser System

    Reg #: 3007284006 · FEI: 3007284006 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPECTRANETICS CORP.
    Registration Number
    3007284006
    FEI Number
    3007284006
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9965 Federal Drive
    City
    Colorado Springs
    State
    CO
    ZIP
    80921
    Country
    US

    Regulatory Submissions

    PMA Number
    P910001

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2939520
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Device, Angioplasty, Laser, Coronary LPC

    Proprietary Names

    CVX-300 Excimer Laser System ELCA Coronary Laser Atherectomy Catheter Philips Laser System

    Establishment Types

    Manufacture Medical Device