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510(k) Data Aggregation

    K Number
    K150813
    Device Name
    iTClamp50
    Date Cleared
    2015-04-30

    (34 days)

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

    INNOVATIVE TRAUMA CARE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iTClamp®50 is a trauma clamp device for the temporary control of severe bleeding in the extremittes, axilla, inguinal areas, scalp, and neck.
    Device Description
    The iTClamp50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The iTClamp50 controls bleeding by sealing the skin closed to apply direct pressure to the cut edges of the skin and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair. The device is provided sterile and is for single use. The iTClamp50 consists of the following components: - 1) Suture needles - 2) Tray w/Tyvek lid - 3) Locking mechanism - 4) Lock release mechanism
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    K Number
    K140805
    Device Name
    ITCLAMP 50
    Date Cleared
    2014-10-09

    (191 days)

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

    INNOVATIVE TRAUMA CARE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.
    Device Description
    The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The iTClamp controls bleeding by sealing the skin closed to apply direct pressure to the cut edges of the skin and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair. The device is provided sterile and is for single use. The iTClamp consists of the following components: - 1) Suture needles - 2) Plastic shell - 3) Locking mechanism - 4) Lock release mechanism
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    K Number
    K132651
    Device Name
    ITCLAMP 50
    Date Cleared
    2013-10-28

    (63 days)

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

    INNOVATIVE TRAUMA CARE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas and scalp.
    Device Description
    The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin/scalp edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The iTClamp controls bleeding by sealing the skin/scalp closed to apply direct pressure to the cut edges of the skin/scalp and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair. The device is provided sterile and is for single use. The iTClamp consists of the following components: 1) Suture needles 2) Plastic shell 3) Locking mechanism 4) Lock release mechanism
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    K Number
    K123551
    Device Name
    ITCLAMP 50
    Date Cleared
    2013-05-14

    (176 days)

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

    INNOVATIVE TRAUMA CARE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ITClamp™ is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla and inguinal areas.
    Device Description
    The ITClamp™ is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The ITClamp is a self-locking surgical clamp with suture needles that penetrate the skin to evert the skin edges between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The ITClamp™ controls bleeding by sealing the skin closed to apply direct pressure and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair. The device is provided sterile and is for single use. The ITClamp™ consists of the following components: 1) Suture needles 2) Plastic Shell 3) Locking mechanism 4) Lock release mechanism
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