BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Valvuloplasty Balloon Catheter (ValvuloPro)

    K Number: K260437 · Decision Mar 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    21
    Applicant Total
    6
    Review Days
    37

    Basic Information

    Device Name
    Valvuloplasty Balloon Catheter (ValvuloPro)
    K Number
    K260437
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1255
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan TT Medical, Inc.
    Date Received
    February 11, 2026
    Decision Date
    March 20, 2026
    Product Code
    OZT
    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
    OZT Balloon Aortic Valvuloplasty

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    Other Clearances by Dongguan TT Medical, Inc.

    K Number Device Name
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    K231814 ValvuloPro Valvuloplasty Balloon Catheter
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