BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spectra Guidewire Introducer Needle

    Reg #: 1224960 · FEI: 3000204727 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPECTRA MEDICAL DEVICES, LLC
    Registration Number
    1224960
    FEI Number
    3000204727
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    299 Ballardvale St Ste 1
    City
    WILMINGTON
    State
    MA
    ZIP
    01887
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082580

    Owner / Operator

    Firm Name
    SPECTRA MEDICAL DEVICES, LLC
    Operator Number
    9012618
    Address
    299 BALLARDVALE STREET, SUITE 1
    City
    Wilmington
    State
    MA
    Postal Code
    01887
    Country
    US

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Spectra Guidewire Introducer Needle

    Establishment Types

    Manufacture Medical Device