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

    Multistage Balloon Dilatation Catheter

    K Number: K222187 · Decision Mar 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    32
    Applicant Total
    6
    Review Days
    222

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    Basic Information

    Device Name
    Multistage Balloon Dilatation Catheter
    K Number
    K222187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan TT Medical, Inc.
    Date Received
    July 22, 2022
    Decision Date
    March 1, 2023
    Product Code
    KTI
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KTI Bronchoscope Accessory

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    Other Clearances by Dongguan TT Medical, Inc.

    K Number Device Name
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    K240967 ValvuloPro Valvuloplasty Balloon Catheter
    K231814 ValvuloPro Valvuloplasty Balloon Catheter
    K230374 Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)
    K222663 MultiStage Balloon Dilatation Catheter