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510(k) Data Aggregation

    K Number
    K153388
    Device Name
    IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle
    Date Cleared
    2016-06-07

    (197 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMPROSAFE® Blood Collection Sets with Pre-attached to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The IMPROVACUTER® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood. The IMPROSAFE® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The IMPROVACUTER® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood. The IMPROSAFE® Multi-Sample Needles (Flashback) are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The IMPROVACUTER® Multi-Sample Needles are used with holder and vacuum blood collection tube for the venous blood collection.
    Device Description
    The proposed devices are blood collection sets form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood. They are available in different configurations as follows: IMPROSAFE® Blood Collection Set with Pre-attached holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, Safety Mechanism, Visible Flash Back IMPROSAFE® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., Safety Mechanism, Visible Flash Back IMPROVACUTER® Blood Collection Set with Pre-attached Holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, N.A., Visible Flash Back IMPROVACUTER® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., N.A., Visible Flash Back IMPROSAFE® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, N.A. IMPROSAFE® Multi Sample Needle (Flashback): Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, Visible Flash Back IMPROVACUTER® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., N.A., N.A., N.A.
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    K Number
    K093910
    Device Name
    IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
    Date Cleared
    2010-07-12

    (202 days)

    Product Code
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.
    Device Description
    The IMPROVACUTER® Gel & Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a Barrier Gel and (4) a plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
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