BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XCELA POWER INJECTABLE PICC

    Reg #: 3030714660 · FEI: 3030714660 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SPECTRUM VASCULAR
    Registration Number
    3030714660
    FEI Number
    3030714660
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 Main St. Suite 1000
    City
    White Plains
    State
    NY
    ZIP
    10606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152409

    Owner / Operator

    Firm Name
    Spectrum Vascular
    Operator Number
    10090343
    Address
    50 Main St. Suite 1000
    City
    White Plains
    State
    NY
    Postal Code
    10606
    Country
    US
    Correspondent
    Sharon Klugewicz

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS

    Proprietary Names

    XCELA POWER INJECTABLE PICC XCELA Hybrid PICC with PASV Valve Technology BIOFLO HYBRID PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY XCELA PICC with PASV Valve Technology BIOFLO PICC WITH ENDEXO TECHNOLOGY BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device