BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

    K Number: K241224 · Decision Nov 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    69
    Applicant Total
    6
    Review Days
    197

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
    K Number
    K241224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings Inc.(Dba Medline Ren
    Date Received
    May 2, 2024
    Decision Date
    November 15, 2024
    Product Code
    NLH
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NLH Catheter, Recording, Electrode, Reprocessed

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    Other Clearances by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

    K Number Device Name
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    K153745 Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
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