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510(k) Data Aggregation

    K Number
    K972914
    Device Name
    SYVEK PATCH
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    1997-12-22

    (137 days)

    Product Code
    KGX
    Regulation Number
    880.5240
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYVEK PATCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Syvek Patch ™ is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a clearance letter from the FDA for the Syvek Patch™ (K972914) dated December 22, 1997. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. The letter simply grants market clearance based on substantial equivalence, implying that the detailed studies proving performance against specific criteria would have been part of the 510(k) submission, but those details are not present in the provided content.

    Therefore, I cannot provide the requested information.

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