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510(k) Data Aggregation

    K Number
    K052416
    Device Name
    PERIPRO PATCH
    Manufacturer
    HANCOCK/JAFFE LABORATORIES
    Date Cleared
    2005-10-25

    (53 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PeriPro™ Patch is indicated for cardiac and vascular reconstruction and repair. This may include intra-cardiac patching and peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial arteries and arteriovenous access revisions.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) K052416 document for the PeriPro™ Patch does not contain any information regarding the acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, or study methodologies that you have requested.

    The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements for the manufacturer. It specifies the product's indications for use but does not detail the studies conducted to establish its safety and effectiveness or how specific performance criteria were met.

    Therefore, I cannot provide the requested table and information based on the text provided.

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