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510(k) Data Aggregation

    K Number
    K061710
    Device Name
    CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS
    Manufacturer
    ST. JUDE MEDICAL
    Date Cleared
    2006-07-14

    (25 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The St. Jude Medical CPS Direct PL Peelable Outer Guide Catheter intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, CPS Direct PL Peelable Outer Guide Catheters can work with inner catheters as a system.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for the CPS Direct™ PL Peelable Outer Guide Catheter.

    The document is an FDA 510(k) clearance letter, which primarily focuses on classifying the device and confirming its substantial equivalence to a predicate device. It defines the "Indications for Use" but does not delve into detailed performance studies or statistical outcomes typically associated with acceptance criteria validation.

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