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510(k) Data Aggregation

    K Number
    K012489
    Device Name
    MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10
    Manufacturer
    APPRIVA MEDICAL, INC.
    Date Cleared
    2001-08-30

    (27 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K002054
    Why did this record match?
    Reference Devices :

    K002054

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

    The X-Sept Transseptal Sheath and Transition Catheter is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text focuses on the 510(k) summary for the X-Sept Transseptal Sheath and Transition Catheter, primarily detailing its substantial equivalence to a predicate device and its intended use. It does not contain information about specific acceptance criteria for a study, reported device performance metrics against such criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type of ground truth used.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given input.

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