# K211741: Pre-Formed Extra Support Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Medical
- Decided: Nov 22, 2021 after 168 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 K930622 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151244: Pre-Formed Guidewire, Lake Region Medical (2015) Summary page 4.

## Indications for use
Pre-Formed Extra Support guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.

Source page: https://510kreport.com/device/K211741
Methodology: https://510kreport.com/methodology