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510(k) Data Aggregation

    K Number
    K042105
    Device Name
    CLIPPER DIAGNOSTIC ELECTRODE CATHETER
    Manufacturer
    BARD ELECTROPHYSIOLOGY
    Date Cleared
    2004-09-23

    (50 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bard Electrophysiology's fixed diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

    Device Description

    6Fwoven fixed curve construction113 – 128cm usable lengthCurve Configurations: Josephson, Cournand, & DamatoElectrode Spacing: 2mm / 5mm / 2mm, 5mm / 1cmNumber of Electrodes: 4Electrode Width: 1.5mm Proximal / 2mm DistalCable: EasyMate

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter for the "Clipper Diagnostic Electrode Catheter."

    This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a randomized clinical trial with specific performance acceptance criteria. The FDA clearance is based on the device having the same intended use and similar technological characteristics as previously cleared devices, and it does not detail specific performance metrics or studies as requested in the prompt.

    Therefore, I cannot provide the requested information based on the provided text.

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