# K232570: Steerant™ Super Stiff Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Oct 24, 2023 after 61 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: 3 generations back to K011906 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101339: Archer Super Stiff Guidewires, Medtronic, Inc. (2010) Summary page 4.

## Indications for use
The Medtronic Steerant Super Stiff Guidewire is intended to be used to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for coronary or neuro vasculature.

Source page: https://510kreport.com/device/K232570
Methodology: https://510kreport.com/methodology