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510(k) Data Aggregation

    K Number
    K041574
    Device Name
    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
    Manufacturer
    GUIDANT CORPORATION
    Date Cleared
    2004-07-12

    (28 days)

    Product Code
    DTD
    Regulation Number
    870.3620
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Model 6017: It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals.
    2. Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal.
    3. Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a Pacemaker Lead Adapter. It does not contain information on acceptance criteria or a study proving that the device meets those criteria. The document only confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information.

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