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510(k) Data Aggregation

    K Number
    K963336
    Device Name
    HARMAC THERMODILUTION CATHETER
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-08-14

    (412 days)

    Product Code
    DYG
    Regulation Number
    870.1240
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HARMAC THERMODILUTION CATHETER

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

    The Balloon Thermodilution catheter is indicated for use in measuring cardiac output by the thermodilution method. In addition, this balloon thermodilution catheter can be used to measure right atrial pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary capillary wedge pressure.

    Device Description

    Harmac Thermodilution Catheter

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Harmac Medical Products, Inc. for their Thermodilution Catheter. This document is primarily an administrative letter confirming substantial equivalence and outlining regulatory compliance.

    It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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