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510(k) Data Aggregation

    K Number
    K142245
    Device Name
    EpiAccess System
    Manufacturer
    EpieP, Inc.
    Date Cleared
    2014-10-29

    (77 days)

    Product Code
    DYBDRSDXG
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    EpieP, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.
    Device Description
    The EpiAccess System consists of the following components and accessories: a sterile, single-use (disposable) Tuohy Type Needle with an integrated, distal, needle tip pressure transducer (sensor), and a reusable integrated Control Unit that includes pre-programmed diagnostic computer with a touchscreen display and graphical user interface (GUI).
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