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510(k) Data Aggregation

    K Number
    K962833
    Device Name
    HARMAC TEMPORARY PACING CATHETER WITH BALLOON
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-15

    (474 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HARMAC TEMPORARY PACING CATHETER WITH BALLOON

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

    The Balloon Temporary Pacing catheter is indicated for use in temporary transvenous ventricular cardiac pacing when impulse formation or conduction is impaired.

    Device Description

    Harmac Temporary Pacing Catheter with Balloon

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Harmac Temporary Pacing Catheter with Balloon. It confirms substantial equivalence to a predicate device and provides information on indications for use. However, it does not include details about specific acceptance criteria or a study proving the device meets them.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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