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510(k) Data Aggregation

    K Number
    K023080
    Device Name
    GALIX PACESTAR
    Manufacturer
    GALIX BIOMEDICAL INSTRUMENTATION, INC.
    Date Cleared
    2003-06-11

    (267 days)

    Product Code
    DTE
    Regulation Number
    870.3600
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GALIX PaceStar External Paccmaker may be used in any clinical situation in which the use of a temporary pacemaker on a patient provides therapentic or diagnostic value. Specifically, indications for teaporary paccusions include, but are not limited to, the following: - temporary treatment of arrhythmias and heart block . - pro-, intra- and postoperative temporary stimulation of patients undergoing cardiac surgery .

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text content does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the GALIX PaceStar External Pacemaker, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

    It details the product name, regulation number, regulatory class, and indications for use. However, it does not include any performance data, acceptance criteria, study details (like sample size, data provenance, expert qualifications, adjudication methods, or ground truth establishment), or information about standalone or comparative effectiveness studies.

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