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

    ValvuloPro Valvuloplasty Balloon Catheter

    K Number: K231814 · Decision Oct 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    21
    Applicant Total
    6
    Review Days
    113

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    Basic Information

    Device Name
    ValvuloPro Valvuloplasty Balloon Catheter
    K Number
    K231814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1255
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan TT Medical, Inc.
    Date Received
    June 21, 2023
    Decision Date
    October 12, 2023
    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
    K260437 Valvuloplasty Balloon Catheter (ValvuloPro)
    K240967 ValvuloPro Valvuloplasty Balloon Catheter
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    K222663 MultiStage Balloon Dilatation Catheter
    K222187 Multistage Balloon Dilatation Catheter