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510(k) Data Aggregation

    K Number
    K131411
    Device Name
    COSEAL
    Manufacturer
    JILIN CORONADO MEDICAL LTD.
    Date Cleared
    2013-09-26

    (134 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    JILIN CORONADO MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoSeal™ Arterial Compression Band is a compression device that indicated to assist hemostasis of the radial artery after a transradial procedure, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist. minimizing the loss of blood.
    Device Description
    The CoSeal™ Arterial Compression Band ("CoSeal Band") is a hemostasis device which works by providing controlled compression on the radial artery without completely occluding blood flow or significantly compressing other structures. It consists of a Velcro belt attached with a balloon, and an injection port. The device also includes a separated syringe (inflator) for injecting air.The CoSeal band is a device that is sterile, for single use, and has a 24month shelf life with one adjustable wristband for different patient size.
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    K Number
    K131124
    Device Name
    COLIGN
    Manufacturer
    JILIN CORONADO MEDICAL LTD.
    Date Cleared
    2013-08-28

    (128 days)

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

    JILIN CORONADO MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoLign™ The Hemostasis Valve is intended to to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French or smaller. The insertion tool facilitates introduction of the guide wire go through the hemostasis valve. The torquer when inserted into the proximal end of the guide wire provides a handle for easier manipulation of the guide wire.
    Device Description
    The CoLign Hemostasis Valve is a device that can be operated with only one hand through its special "push-pull" mechanism. In the pushed-down position, the valve is open for safe insertion and removal of devices. In the pulled-up position, the valve is closed and seals smoothly round the inserted devices. Once the valve is closed, devices can still be manipulated freely. CoLign eliminates the need for adjustment of the hemostasis valve by rotating during the procedure. The CoLign Hemostasis Valve is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the CoLign Hemostasis Valve: the Standard CoLign , the CoLign 20,and the CoLign 50. The configuration of the sideport is the only difference among the three models. The sideport of the Standard CoLign ends in a male luer, while the sidearm of the CoLign 20/50 ends with a 20/50 cm extension tubing and 3-way stopcock.
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