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510(k) Data Aggregation

    K Number
    K231402
    Device Name
    HP PTA Balloon Dilatation Catheter
    Manufacturer
    Kossel Medtech (Suzhou) Co.,Ltd.
    Date Cleared
    2023-12-20

    (219 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kossel Medtech (Suzhou) Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HP PTA Balloon Dilation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, popliteal, tibial, peroneal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
    Device Description
    The 0.0350" HP PTA balloon dilatation catheter is mainly composed of tip tube, inner tube, balloon, marker bands, double-lumen tube, stress diffusion tube and hub. Among them the balloon is the most important part of the catheter. In order to dilate different stenosis, the balloon should be dilated to different dimensions by inflating to different pressures. The soft tip at the end of the balloon is intended to make the balloon catheter more easy to push to the stenosis position. The inner tube which connects to the tip tube is for guide wire passage and the pushing rod. The two marker bands wrapped around the inner tube are for positioning the balloon location with the use of in vitro monitoring equipment. The proximal end of the double-lumen tube is connected with the hub, which is used as the balloon filling channel and also as the push rod of the catheter. The hub is used to connect with the external pressure equipment for balloon filling. The stress diffusion tube can prevent the double-lumen tube from being folded.
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