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510(k) Data Aggregation

    K Number
    K210516
    Device Name
    Clicky Cross
    Manufacturer
    Yomura Technologies Inc.
    Date Cleared
    2022-05-16

    (447 days)

    Product Code
    FMG
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Yomura Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clicky Cros™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.
    Device Description
    Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids. Yomura Clicky Cross™ is a new medical device using as flow control switch and is developed by Yomura Technologies Inc. Click-release process via one-handed operation Less leakage issue than currently commercial products Stopcock system for I.V. set and other application Suitable for all current pressure infusion system There are two types of fitting end (Barb /Luer) for normal I.V. infusion sets. In order to meet the requirement of I.V. infusion set, here we provide two different types of fitting end (Barb/Luer).
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    K Number
    K112542
    Device Name
    YOMURA SAFETY I.V. CATHETER
    Manufacturer
    YOMURA TECHNOLOGIES INC.
    Date Cleared
    2012-02-08

    (160 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    YOMURA TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YOMURA Safety I.V. Catheter is to be inserted into patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
    Device Description
    The Yomura Safety I.V. Catheter consists of a catheter connected to a standard conical fitting, and a safety mechanism. Upon activation of the safety mechanism the needle guard covers the entire length of the needle. Therefore, the risks of needle stick injuries can be reduced. The YOMURA Safety I.V. Catheter consists of an over needle peripheral catheter made of polyurethane material with radiopaque stripes. The stainless steel needle is placed in the catheter to maintain rigidity and to facilitate venipuncture. A safety mechanism constitutes a needle guard is built inside the device. Upon insertion and threading of the catheter, the needle guard extends to full length and locks into place to encapsulate the entire length of the needle. Thus adds in the prevention of accidental needle stick injuries.
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