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Confida Brecker Guidewire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K150465

by Medtronic Core Valve, LLC

Identifiers

510(k) Number
K150465 FDA 510(k)
FDA Product Code
DQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Confida Brecker Guidewire is a guidewire designed for use in transcatheter aortic valve replacement (TAVR) procedures. It is classified under the nomenclature category of catheter guide wires (product code DQX) and is intended for navigating and positioning catheters within the cardiovascular system during interventional procedures.

This device is supplied as a single-use, sterile product and is regulated under 21 CFR 870.1330 as a Class II medical device. It is intended for use in controlled clinical settings, such as cardiac catheterization labs, and requires proper storage to maintain sterility. The device holds an FDA 510(k) clearance (K181001) for substantial equivalence to a predicate device.

Frequently asked questions

What is the primary use of the Medtronic Confida Brecker Guidewire in a clinical setting?

The Medtronic Confida Brecker Guidewire is specifically designed for use during transcatheter aortic valve replacement (TAVR) procedures. Its purpose is to assist in navigating and positioning catheters within the cardiovascular system, ensuring precise placement during interventional cardiac catheterization.

Is the Medtronic Confida Brecker Guidewire intended for single-use or repeated use?

The Medtronic Confida Brecker Guidewire is supplied as a single-use device. This design choice helps maintain sterility and safety, as it is intended for use in controlled clinical settings like cardiac catheterization labs where contamination risks must be minimized.

How should the Medtronic Confida Brecker Guidewire be stored to ensure it remains sterile?

The device must be stored according to manufacturer guidelines to preserve sterility, as it is supplied in a sterile package. Proper storage conditions are critical, particularly in clinical settings where it will be used, to prevent compromise of its sterile integrity before use.

What regulatory pathway was followed for the FDA clearance of the Medtronic Confida Brecker Guidewire?

The Medtronic Confida Brecker Guidewire received FDA clearance through a traditional 510(k) process, specifically under the product code DQX (catheter guide wires). It was determined to be substantially equivalent to a predicate device, with a clearance date of August 3, 2015, and the 510(k) number K150465.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Confida™ Brecker guidewire - Medtronic, K181001 FDA 510 (k) - Medtronic Confida Brecker Guidewire, Medtronic Confida Brecker Guidewire (K181001) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Core Valve, LLC

Sources (1)

  • FDA 510(k) K150465 24 fields · synced Oct 6, 2026