BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Palindrome SI Chronic Catheter Kits and Sport Packs

    Reg #: 1282497 · FEI: 1282497 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Covidien LLC
    Registration Number
    1282497
    FEI Number
    1282497
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15 HAMPSHIRE STREET
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112477

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US
    Correspondent
    Tania Pearson

    Products

    Device Name Product Code
    Catheter, Hemodialysis, Implanted MSD
    Catheter, Hemodialysis, Implanted, Coated NYU

    Proprietary Names

    Palindrome SI Chronic Catheter Kits and Sport Packs Palindrome H Chronic Catheter Kits and Sport Packs Palindrome HSI Chronic Catheter Kits and Sport Packs

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility