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510(k) Data Aggregation

    K Number
    K021129
    Device Name
    CHARE CARIOVASCULAR PATCH
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2002-06-03

    (56 days)

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

    CHARE CARIOVASCULAR PATCH

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

    The CHASE Cardiovascular Patch With Radiopaque Markings is indicated for cardiac and vascular patch grafting.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. This document is an FDA 510(k) clearance letter for a medical device called "Cardiovascular Patch With Radiopaque Markings," indicating it has been deemed substantially equivalent to a legally marketed predicate device. It does not include the details of a study with acceptance criteria and performance metrics.

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