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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).

The Medtronic ConfidaTM 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 ConfidaTM Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic ConfidaTM Brecker Guidewire is an external communicating device having limited contact (<24 hours) with circulating blood. The Medtronic ConfidaTM Brecker Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity. The Medtronic ConfidaTM 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 ConfidaTM Brecker Guidewire is sterilized via Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6. The purpose of this 510(k) is to notify FDA of a change to the PTFE coating applied to the core wire section of the ConfidaTM Brecker Guidewire. The change is to replace the existing low Chromium VI PTFE coating with Chromium VI free PTFE coating.