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510(k) Data Aggregation

    K Number
    K123842
    Device Name
    LAWMAX DILATOR
    Manufacturer
    LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.
    Date Cleared
    2013-06-24

    (193 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LawMax™ Dilator is intended for use in the dilation of the peripheral vasculature.
    Device Description
    LawMax™ dilator is intended to dilate the puncture tunnel of the skin, subcutaneous tissue and vascular wall. The device is compised of a dilator tube and a handle connected to its proximal end. There is a lumen in the tube center from distal end to proximal end which can accept a 0.038 inch guide wire. The tube surface is coatings which can reduce the friction during the insertion manipulation. Operator can monitor the tube using fluoroscope guidance. A handle groximal end of the tube is available to facilitate operation. There is a hemostasis valve which can be adjusted to prevent blood leaking. The specification of LawMax™ dilator is definite by the outer diameter of the cylindrical part of the tube.
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    K Number
    K100184
    Device Name
    FUSTAR STEERABLE INTRODUCERS
    Manufacturer
    LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.
    Date Cleared
    2011-02-14

    (389 days)

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

    LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FuStar™ Steerable Introducer is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
    Device Description
    The FuStar™ Steerable Introducers are designed to perform as a guiding sheath and/or introducer sheath, which provides a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low-profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of catheters and devices. The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm (Large). In each option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination. Also, the visible knob with scale of controller facilitates the physicians to estimate the deflecting angle of the sheath while intra-operation. The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French size, 5F, 6F, 7F, 8F, 9F and 10F). The deflectable angle of sheath is from 0 degree to 180 degree.
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    K Number
    K102484
    Device Name
    SEQURE SNARE SYSTEM
    Manufacturer
    LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.
    Date Cleared
    2010-11-09

    (71 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SeQure™ Snare System is intended for use in the cardiovascular system as a tool to retrieve and manipulate foreign objects.
    Device Description
    The SeQure™ Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformation because of super-elasticity of nitinol material. The catheter connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter.
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