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

    Sphere-9Dx Diagnostic Catheter (AFR-00009)

    K Number: K233433 · Decision Aug 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    33
    Applicant Total
    33
    Review Days
    300

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    Basic Information

    Device Name
    Sphere-9Dx Diagnostic Catheter (AFR-00009)
    K Number
    K233433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic
    Date Received
    October 12, 2023
    Decision Date
    August 7, 2024
    Product Code
    MTD
    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
    MTD Catheter, Intracardiac Mapping, High-Density Array

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