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510(k) Data Aggregation

    K Number
    K212359
    Device Name
    PWD Negative Pressure Wound Therapy System
    Date Cleared
    2022-09-21

    (419 days)

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

    Applied Tissue Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies), flaps, grafts and closed surgical incisions. PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
    Device Description
    The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System consists of the PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump and the Wound exudate canister. The system provides a negative pressure wound dressing therapy in a moist environment to facilitate the wound healing process. The dressing has an access port through which fluids can be drawn from the wound site. The same port can also be utilized to administer negative pressure wound therapy using the negative pressure pump if required. The negative pressure pump is used with a collection cannister to collect the exudate. The PWD Platform Wound Dressing is supplied in five different shapes and sizes, all having the same intended use.
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    K Number
    K191460
    Device Name
    PWD Platform Wound Dressing 3” x 5” Oblong
    Date Cleared
    2019-07-02

    (29 days)

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

    Applied Tissue Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Applied Tissue Technologies PWD™ Platform Wound Dressing is intended to be used in conjunction with the Invia Motion Negative Pressure Wound Therapy (NPWT) system and is indicated in patients who would benefit from a suction device (NPWT) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts.
    Device Description
    The Applied Tissue Technologies PWDTM Platform Wound Dressing is a single use device. Its transparency permits the healthcare practitioner to observe the progress of the wound healing without removing the wound dressing. There is an access port to administer negative pressure wound therapy. The PWD is intended to be used for a maximum of 3 days. Therapy duration may be less than indicated if clinical practice or other factors require more frequent dressing changes. The PWD will be marketed in five different shapes and sizes, all having the same intended use. The five sizes are identified as follows. PWDTM Platform Wound Dressing Description | Catalog/REF # 1" Round | AT1070-01 2" Round | AT1071-01 3" Round | AT1072-01 1" x 3" Oblong | AT1073-01 3" x 5" Oblong | AT1074-01
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    K Number
    K182409
    Device Name
    Applied Tissue Technologies PWD™ Platform Wound Dressing
    Date Cleared
    2019-01-11

    (129 days)

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

    Applied Tissue Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Applied Tissue Technologies PWD™ Platform Wound Dressing is intended to be used in conjunction with the Invia Motion Negative Pressure Wound Therapy (NPWT) system and is indicated in patients who would benefit from a suction device (NPWT) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts.
    Device Description
    The Applied Tissue Technologies PWD™ Platform Wound Dressing is a single use device. Its transparency permits the healthcare practitioner to observe the progress of the wound healing without removing the wound dressing. There is an access port to administer negative pressure wound therapy. The PWD is intended to be used for a maximum of 3 days. Therapy duration may be less than indicated if clinical practice or other factors require more frequent dressing changes. The PWD will be marketed in four different shapes and sizes, all having the same intended use.
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