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510(k) Data Aggregation

    K Number
    K172763
    Device Name
    Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder
    Manufacturer
    Zhejiang Kindly Medical Devices Co.,Ltd
    Date Cleared
    2018-06-04

    (264 days)

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

    Zhejiang Kindly Medical Devices Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting Set is intended to be used with vacuum blood collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
    Device Description
    The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube. The patient-end needle is punctured into vein, and non-patient end needle will penetrate into vacuum blood collection tube, blood will flow into blood collection tube under the action of differential pressure. The proposed devices are divided into several types and available in different specifications.
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