# K150465: Medtronic Confida Brecker Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Core Valve, LLC
- Decided: Aug 3, 2015 after 161 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K920884 (1992). 8 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132623: Medtronic Confida Brecker Curve Guidewire, Medtronic (2013) Summary page 4.

## Most influential descendants
- K181001: Medtronic Confida Brecker Guidewire (2018), 8 descendants of its own
- K192454: Wattson Temporary Pacing Guidewire (2020), 6 descendants of its own
- K213854: SavvyWire (2022), 4 descendants of its own
- K241418: OptoMonitor 3 (2025), 1 descendant of its own
- K251367: OptoMonitor 3 (2026), 0 descendants of its own

## Indications for 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)

Source page: https://510kreport.com/device/K150465
Methodology: https://510kreport.com/methodology