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510(k) Data Aggregation

    K Number
    K061727
    Device Name
    GORE PRECLUDE VESSEL GUARD
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Date Cleared
    2006-08-07

    (49 days)

    Product Code
    MFX
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    MFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GORE PRECLUDE® Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery to reduce the risk of potential vessel damage during a revision surgery by providing a plane of dissection.
    Device Description
    Not Found
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    K Number
    K960532
    Device Name
    PRECLUDE IMA SLEEVE
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Date Cleared
    1996-05-23

    (106 days)

    Product Code
    MFX
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    MFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a wrap for pedicled arterial conduits. The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery.
    Device Description
    Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve configuration. The sleeve configuration allows a surgeon to use the device as is without the need to form and shape the device during surgical procedures. The sleeve has a nominal 17-24 mm internal diameter and a length of 10-20 cm.
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