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510(k) Data Aggregation

    K Number
    K111333
    Device Name
    ANTLIA III WOUND TREATMENT SYSTEM
    Manufacturer
    INNOVATIVE THERAPIES, INC.
    Date Cleared
    2011-08-08

    (88 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE THERAPIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Antlia III™ Wound Treatment System is indicated for the application of suction (negative pressure) to wounds as it may promote wound healing and for the removal of fluid, including wound exudates, irrigation fluids, body fluids and infectious materials.
    Device Description
    The Antlia III™ Wound Treatment System is an AC-powered, portable suction device with battery backup that provides localized negative pressure when used with the ITI Dressing to remove fluid and infectious materials from the wound as it may promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds. The Antlia III™ Wound Treatment System consists of the same powered suction pump components and functions the same as the Antlia II Suction Pump device, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the ITI 300cc and 500cc collection canisters, and optional pressure settings of -50mmHg, -75mmHg, -100mmHg, - 125mmHg, and -150mmHg.
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    K Number
    K093564
    Device Name
    SVED WOUND TREATMENT SYSTEM
    Manufacturer
    INNOVATIVE THERAPIES, INC.
    Date Cleared
    2009-11-25

    (7 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE THERAPIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sved® Wound Treatment System is indicated for patients who would benefit from an AC-powered, portable suction device with battery backup that provides vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The Sved® Wound Treatment System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts. The specifically designed SVAMP® dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.
    Device Description
    The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the 300cc Sved® collection canister. The Svamp™ Wound Dressing components remain the same and are provided in Small, Medium, Large and XL sizes of the polyurethane foam dressing.
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    K Number
    K071301
    Device Name
    ANTLIA I WOUND IRRIGATION SYSTEM
    Manufacturer
    INNOVATIVE THERAPIES, INC.
    Date Cleared
    2007-05-24

    (15 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE THERAPIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANTILIA 1™ Wound Irrigation System device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The ANTLIA 1 TM Wound Irrigation System is intended for patients with chronic, acute, traumatic, subacute, and dehised wounds, diabetic with with with churches, filaps and grafts.
    Device Description
    The ANTLIA I™ Wound Irrigation System is an AC-powered, portable suction device with battery back-up that provides vacuum assisted drainage and irrigation of a wound site by controlled delivery of topical wound treatment solutions over the wound bed. The specifically designed Aquarius I™ dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.
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    K Number
    K070904
    Device Name
    ANTLIA II SUCTION PUMP SYSTEM
    Manufacturer
    INNOVATIVE THERAPIES, INC.
    Date Cleared
    2007-04-13

    (11 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE THERAPIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANTLIA II™ Suction Pump System is indicated for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.
    Device Description
    The ANTLIA IIm Suction Pump System, an AC-powered, portable suction device with battery back-up, provides localized negative pressure when used with the Aquarius IITM dressing to remove fluids and infectious materials from the wound to promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds. The system consists of a powered suction pump device with a built-in placement holder for a fluid collection canister, the Aquarius II TM polyurethane foam dressing, and canister tubing with clamps and connectors, and two polyurethane drapes with adhesive.
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