Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K140367
    Device Name
    ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
    Date Cleared
    2014-09-12

    (210 days)

    Product Code
    Regulation Number
    N/A
    Why 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.
    Ask a Question

    Ask a specific question about this device

    K Number
    K122502
    Device Name
    BRIDGE EXTRACELLULAR COLLEGEN MATRIX
    Date Cleared
    2013-02-26

    (194 days)

    Product Code
    Regulation Number
    N/A
    Why 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.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1