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510(k) Data Aggregation

    K Number
    K220981
    Device Name
    SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
    Manufacturer
    Fehling Surgical Instruments, Inc.
    Date Cleared
    2023-04-20

    (381 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fehling Surgical Instruments, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
    Device Description
    The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters. The coronary probe is available in different lengths and diameters to accommodate the needs of various surgical procedures and vessel anatomies. The probe is constructed of Titanium Alloy (TiAl6V4), Nitinol, and Titanium (Grade 2). Coronary probes are supplied non-sterile.
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