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510(k) Data Aggregation

    K Number
    K070816
    Device Name
    PERIPHERAL GUIDING SHEATH
    Date Cleared
    2007-09-19

    (177 days)

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

    MICRUS DESIGN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Micrus Design Technology Peripheral Guiding Sheaths are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
    Device Description
    The Micrus Design Technology Peripheral Guiding Sheaths are single lumen catheters, incorporating a Pebax body reinforced with a stainless steel wire coil. The intermediate segment is also Pebax with a stainless steel coil to reduce kinking and to promote improved torque response. They are available in 5 Fr, 6Fr, 7Fr, and 8 Fr and 45 cm, 55 cm and 90 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
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