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510(k) Data Aggregation

    K Number
    K964467
    Device Name
    SHELHIGH PERICARDIAL PATCH
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    1997-09-23

    (320 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SHELHIGH PERICARDIAL PATCH

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

    The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the "Shelhigh Pericardial Patch (without detoxification treatment)" and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance studies, or the methodologies used to establish such criteria and conduct studies.

    Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not delve into the technical details of its performance or the studies behind it.

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