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510(k) Data Aggregation

    K Number
    K042308
    Device Name
    SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019
    Manufacturer
    FACILE MEDICAL, INC.
    Date Cleared
    2005-02-17

    (176 days)

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

    FACILE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sheath-in Sheath Catheter is designed to facilitate the entry of interventional devices into the vessels of the cardiovascular system.
    Device Description
    Not Found
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