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

    Paragon 8F Balloon Guide Catheter

    K Number: K232437 · Decision Oct 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    5
    Review Days
    60

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    Basic Information

    Device Name
    Paragon 8F Balloon Guide Catheter
    K Number
    K232437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wallaby Medical
    Date Received
    August 14, 2023
    Decision Date
    October 13, 2023
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQY Catheter, Percutaneous

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