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510(k) Data Aggregation

    K Number
    K203459
    Device Name
    SafeCross Transseptal Puncture and Introducer (TSP/I) System
    Manufacturer
    East End Medical I LLC
    Date Cleared
    2021-07-06

    (224 days)

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

    East End Medical I LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SafeCross Transseptal Puncture Device and Introducer (TSP/I) System is used to introduce various cardiovascular catheters to the heart, including the left side of the heart. The system enables left heart access through a puncture of the atrial septum during a transseptal catheterization procedure. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.
    Device Description
    The SafeCross Transseptal Puncture and Introducer (TSP/I) System is used to access the heart left atrium through a puncture of the atrial septum. The System includes three (3) components: the Steerable Introducer Sheath, the RF Puncture Member, and an Access Dilator. The Steerable Introducer Sheath has a compliant balloon at the tip for protection of the septum, and the RF Puncture member is compatible with five (5) of the most common electrosurgical generators.
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