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510(k) Data Aggregation
K Number
K140367Device Name
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
Manufacturer
Date Cleared
2014-09-12
(210 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HARBOR MEDTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Harbor MedTech Architect™ Px Extracellular Collagen Matrix is indicated for the local management of moderately to heavy exuding wounds, including:
· Partial and full thickness wounds,
- · Draining wounds,
· Pressure sores/ulcers,
· Venous ulcers,
· Chronic vascular ulcers,
· Diabetic ulcers,
· Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
· Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incisions)
Device Description
The Harbor MedTech Architect™ Px Extracellular Collagen Matrix (ECM) is a decellularized equine pericardial device The Architect™ Px ECM is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.
The Architect™ Px ECM is available in multiple sizes. The Architect™ Px ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix.
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K Number
K122502Device Name
BRIDGE EXTRACELLULAR COLLEGEN MATRIX
Manufacturer
Date Cleared
2013-02-26
(194 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HARBOR MEDTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- Draining wounds, .
- Pressure sores/ulcers. .
- Venous ulcers, ●
- Chronic vascular ulcers, .
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)
Device Description
The Harbor MedTech BriDGE Extracellular Collagen Matrix (ECM) Wound Dressing is a decellularized equine pericardial device that has been stabilized and radiation sterilized. The BriDGE ECM is non-pyrogenic and is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.
The BriDGE ECM is available in four sizes. The BriDGE ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix.
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