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510(k) Data Aggregation

    K Number
    K113148
    Device Name
    E-PASS
    Manufacturer
    SYNEXMED(SHENZHEN)COMPANY LIMITED
    Date Cleared
    2012-02-28

    (127 days)

    Product Code
    DTL, DQX
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNEXMED(SHENZHEN)COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-Pass is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French. The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter. The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.
    Device Description
    The E-Pass is a unique one-hand operated, "push-pull" hemostatic valve system. It consists of two pieces of silicone hemostasis valve. The quick open-close valve reduces the patient blood loss significantly during endovascular procedures. In the push forward position the valves is 100% open for safe insertion and removal of devices. In the pulled back position the valve is 100% closed and seals smoothly around the inserted devices. Once the valve is closed, devices can still be manipulated freely. E-Pass eliminates the need for rotating hemostatic valve adjustments during the procedure. The E-Pass hemostatic valve system is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the E-Pass: the standard E-Pass and the E-Pass20/E-Pass50. The configuration of the sideport is the only difference among the three models. The sideport of the standard E-Pass ends in a female luer, while the sidearm of the E-Pass 20/ 50ends with a 20/50 cm extension tubing and 3-way stopcock.
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