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510(k) Data Aggregation

    K Number
    K150465
    Device Name
    Medtronic Confida Brecker Guidewire
    Manufacturer
    Medtronic CoreValve, LLC.
    Date Cleared
    2015-08-03

    (161 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medtronic CoreValve, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic ConfidaTM Brecker Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).
    Device Description
    The Medtronic Confida™ Brecker Guidewire was developed for use in diagnostic and interventional procedures including transcatheter aortic valve implantation (TAVI) procedures for the treatment of aortic valve disease. The Medtronic ConfidaTM Brecker Guidewire (model number GWBC30) is available in one size and is comprised of a stainless steel wire, 0.035" in diameter, and 260cm in length. The distal end of the Medtronic Confida™ Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic Confida™ Brecker Guidewire is an external communicating device having limited (<24 hours) with circulating blood. The Medtronic Confida™ Brecker Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity. The Medtronic Confida™ Brecker Guidewire is a patient contacting, single use only device and not intended for re-use or re-sterilization. The device is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures. The Medtronic Confida™ Brecker Guidewire is sterilized via Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6.
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