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510(k) Data Aggregation
K Number
K212359Device Name
PWD Negative Pressure Wound Therapy System
Manufacturer
Date Cleared
2022-09-21
(419 days)
Product Code
Regulation Number
878.4780Why 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
K191460Device Name
PWD Platform Wound Dressing 3 x 5 Oblong
Manufacturer
Date Cleared
2019-07-02
(29 days)
Product Code
Regulation Number
878.4780Why 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
K182409Device Name
Applied Tissue Technologies PWD Platform Wound Dressing
Manufacturer
Date Cleared
2019-01-11
(129 days)
Product Code
Regulation Number
878.4780Why 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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