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510(k) Data Aggregation

    K Number
    K243553
    Device Name
    QuikClot Control+ Hemostatic Device
    Manufacturer
    Teleflex Medical
    Date Cleared
    2025-03-18

    (120 days)

    Product Code
    POD
    Regulation Number
    878.4454
    Why did this record match?
    Product Code :

    POD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.
    Device Description
    QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal.
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    K Number
    K213198
    Device Name
    Ax-Surgi Surgical Hemostat
    Manufacturer
    Advamedica Inc.
    Date Cleared
    2023-01-05

    (463 days)

    Product Code
    POD
    Regulation Number
    878.4454
    Why did this record match?
    Product Code :

    POD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.
    Device Description
    The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.
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    K Number
    K220971
    Device Name
    QuikClot Control+ Hemostatic Dressing
    Manufacturer
    Z-Medica, LLC
    Date Cleared
    2022-12-14

    (254 days)

    Product Code
    POD
    Regulation Number
    878.4454
    Why did this record match?
    Product Code :

    POD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying class III or class IV bleeding. Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy.
    Device Description
    QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes and configurations. The device is available in single or multipacks.
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    K Number
    K200167
    Device Name
    QuikClot Control+
    Manufacturer
    Z-Medica, LLC
    Date Cleared
    2020-04-23

    (91 days)

    Product Code
    POD
    Regulation Number
    878.4454
    Why did this record match?
    Product Code :

    POD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
    Device Description
    QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes. The device is available in single or multipacks.
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    K Number
    K183190
    Device Name
    NuStat
    Manufacturer
    Beeken Biomedical, LLC
    Date Cleared
    2019-09-25

    (310 days)

    Product Code
    POD
    Regulation Number
    878.4454
    Why did this record match?
    Product Code :

    POD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
    Device Description
    The NuStat is a hemostatic wound dressing that is composed of continuous filament silica and bamboo cellulose rayon fiber and is provided with radiopaque thread. The distribution of cellulose and silica fibers in each dressing is 65% silica fiber and 35% bamboo cellulose rayon fiber. The dressings are available in various sizes and provided sterile in either foil, Tyvek, or LDPE pouched configurations. The NuStat hemostatic wound dressings have a number of hemostatic properties that enhance the ability of the dressing to temporarily control bleeding. NuStat Hemostatic Dressing's mode of action is via absorption of fluid, which results in a physical aggregation of blood cells and clotting factors at the site of application. The radiopaque element allows for detection via x-ray.
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    K Number
    DEN160012
    Device Name
    D2 Dressing
    Manufacturer
    Z-MEDICA, LLC
    Date Cleared
    2017-06-30

    (471 days)

    Product Code
    POD
    Regulation Number
    878.4454
    Why did this record match?
    Product Code :

    POD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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