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510(k) Data Aggregation

    K Number
    K220881
    Device Name
    INOUE BALLOON A
    Manufacturer
    Toray Industries, Inc.
    Date Cleared
    2022-12-18

    (268 days)

    Product Code
    OZT
    Regulation Number
    870.1255
    Why did this record match?
    Applicant Name (Manufacturer) :

    Toray Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INOUE BALLOON™ A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.
    Device Description
    INOUE BALLOON™ A is intended for the treatment of patients with aortic valvuloplasty (BAV). The device is transported over a guidewire as it is inserted through a percutaneous entry site and expanded with a predetermined amount of the diluted contrast medium by use of specified syringe with extension tube connected to the balloon inflation luer-lock hub. This results in the staged inflation of the balloon from hour-glass to barrel shape. The balloon is stretched and made thinner by pushing the inner tube in during passing thorough the introducer sheath. A radiopaque marker is provided for fluoroscopic positioning of the device across the valve.
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