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510(k) Data Aggregation

    K Number
    K141685
    Device Name
    CROC
    Manufacturer
    COMBAT MEDICAL SYSTEMS, LLC
    Date Cleared
    2015-01-26

    (217 days)

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

    COMBAT MEDICAL SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRoC™ is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.
    Device Description
    The CRoC™ is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The CRoC™ is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.
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    K Number
    K130482
    Device Name
    COMBAT READY CLAMP
    Manufacturer
    COMBAT MEDICAL SYSTEMS, LLC
    Date Cleared
    2013-04-29

    (63 days)

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

    COMBAT MEDICAL SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas.
    Device Description
    The CRoC™ is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.
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    K Number
    K102025
    Device Name
    COMBAT READY CLAMP
    Manufacturer
    COMBAT MEDICAL SYSTEMS, LLC
    Date Cleared
    2010-08-11

    (23 days)

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

    COMBAT MEDICAL SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
    Device Description
    The Combat Ready Clamp is designed to be used by Military medical personnel in the battlefield. The device is designed to control bleeding in the inguinal area where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries or soldiers. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured soldier can be transferred to evacuation personnel for further treatment.
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