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510(k) Data Aggregation

    K Number
    K012392
    Device Name
    DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
    Manufacturer
    PACE MEDICAL
    Date Cleared
    2001-09-04

    (39 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260

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

    For use in conjunction with a Model 4815 Adapter for connecting a non-sterile pacing (system) analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be located at some distance from the patient, outside of the sterile field.

    Device Description

    Model 4255 or Model 4260 Disposable Extension Cables

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Model 4255 or Model 4260 Disposable Extension Cables." It primarily states that the device is substantially equivalent to a predicate device and can be marketed. It does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or specific performance metrics.

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