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510(k) Data Aggregation

    K Number
    K260437

    Validate with FDA (Live)

    Device Name
    Valvuloplasty Balloon Catheter (ValvuloPro)
    Manufacturer
    Dongguan TT Medical, Inc.
    Date Cleared
    2026-03-20

    (37 days)

    Product Code
    OZT
    Regulation Number
    870.1255
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K240967
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ValvuloPro Valvuloplasty Balloon Catheter is indicated for balloon aortic vavuloplasty.

    Device Description

    The ValvuloPro Valvuloplasty Balloon Catheter is intended for use in balloon aortic valvuloplasty procedures. The device consists of an inflatable balloon mounted at the distal end of a coaxial catheter shaft. The catheter has an effective working length of 130 cm.

    The proximal end of the catheter is equipped with a Y-shaped hub, comprising one port dedicated to balloon inflation and deflation and a second port designed for guidewire access. Two radiopaque tantalum marker bands are positioned at the proximal and distal shoulders of the balloon, providing fluoroscopic visualization to facilitate accurate balloon placement across the target valvular stenosis.

    The balloon catheter is sterilized using ethylene oxide and is intended for single use only.

    AI/ML Overview

    N/A

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