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

    Accusafe Transseptal Guidewire (GTR31180, GTR31230)

    K Number: K240246 · Decision Jul 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    4
    Review Days
    178

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    Basic Information

    Device Name
    Accusafe Transseptal Guidewire (GTR31180, GTR31230)
    K Number
    K240246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synaptic Medical Corporation
    Date Received
    January 30, 2024
    Decision Date
    July 26, 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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