# K250075: Medtronic Stedi Extra Support Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jun 13, 2025 after 154 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: 6 generations back to K920884 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181001: Medtronic Confida Brecker Guidewire, Medtronic Core Valve, LLC (2018) Summary page 5.

## Indications for use
Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

Source page: https://510kreport.com/device/K250075
Methodology: https://510kreport.com/methodology