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

    ValvuloPro Valvuloplasty Balloon Catheter

    K Number: K240967 · Decision Jul 31, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    21
    Applicant Total
    6
    Review Days
    113

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ValvuloPro Valvuloplasty Balloon Catheter
    K Number
    K240967
    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
    April 9, 2024
    Decision Date
    July 31, 2024
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OZT), ordered by most recent decision date.

    KardiaPSI Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Valvuloplasty Balloon Catheter (ValvuloPro)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OutFlo Aortic Valve Dilatation Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ValvuloPro Valvuloplasty Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INOUE BALLOON A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    True Flow Valvuloplasty Perfusion Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Dongguan TT Medical, Inc.

    K Number Device Name
    K260437 Valvuloplasty Balloon Catheter (ValvuloPro)
    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
    K222187 Multistage Balloon Dilatation Catheter