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510(k) Data Aggregation

    K Number
    K242248
    Device Name
    Introducer Sheath Kits
    Manufacturer
    Beijing Demax Medical Technology Co., Ltd.
    Date Cleared
    2024-08-22

    (22 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Demax Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.
    Device Description
    Not Found
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    K Number
    K222184
    Device Name
    Introducer Sheath Kits
    Manufacturer
    Beijing Demax Medical Technology Co., Ltd.
    Date Cleared
    2023-02-21

    (214 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Demax Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.
    Device Description
    Not Found
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    K Number
    K222182
    Device Name
    Radial Artery Compression Tourniquets
    Manufacturer
    Beijing Demax Medical Technology Co., Ltd.
    Date Cleared
    2023-01-04

    (166 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Demax Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.
    Device Description
    Radial Artery Compression Tourniquets
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    K Number
    K140943
    Device Name
    MASTRO PLUS BALLOON IN-DEFLATION DEVICE
    Manufacturer
    BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2015-03-05

    (325 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.
    Device Description
    The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. The balloon in-deflation device mainly composes of four parts, injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure.
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