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510(k) Data Aggregation

    K Number
    K111603
    Device Name
    LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
    Manufacturer
    EP DYNAMICS, INC.
    Date Cleared
    2012-08-23

    (442 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM

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

    The EP Dynamics, Inc., LineBacker™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for a medical device (LineBacker Transseptal Introducer). This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

    FDA 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on meeting specific performance criteria through a detailed study in the same way a PMA (Premarket Approval) might require. The letter primarily confirms that the FDA has reviewed the submission and found the device substantially equivalent for its stated indications for use.

    Therefore, I cannot extract the requested information from the provided text.

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