# K181001: Medtronic Confida Brecker Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Core Valve, LLC
- Decided: May 3, 2018 after 17 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: 5 generations back to K920884 (1992). 9 ancestors in all.
8 later devices descend from it; 2 cite 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)
- K150465: Medtronic Confida Brecker Guidewire, Medtronic Core Valve, LLC (2015) Summary page 4.

## Most influential descendants
- 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
- K252674: Solo Pace Fusion System (SOLOFUSE1) (2026), 0 descendants of its own

## Indications for use
The Medtronic Confida™ 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/K181001
Methodology: https://510kreport.com/methodology