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

    SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

    K Number: K241042 · Decision May 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    9
    Review Days
    30

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    Basic Information

    Device Name
    SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
    K Number
    K241042
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pressure Products Medical Device Manufacturing, LLC
    Date Received
    April 17, 2024
    Decision Date
    May 17, 2024
    Product Code
    DRC
    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
    DRC Trocar

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    Other Clearances by Pressure Products Medical Device Manufacturing, LLC

    K Number Device Name
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