# K253746: Enroute 0.014'' Transcarotid Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Medical
- Decided: Mar 19, 2026 after 114 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: 7 generations back to K970376 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160643: ENROUTE 0.014 Guidewire, Lake Region Medical (2016) Summary page 5.

## Indications for use
The Enroute Transcarotid 0.014'' Guidewire is intended for use in the peripheral vasculature, inclusive of the carotid artery.

Source page: https://510kreport.com/device/K253746
Methodology: https://510kreport.com/methodology