# K160643: ENROUTE 0.014 Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Medical
- Decided: Oct 18, 2016 after 225 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 K970376 (1997). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060551: Brivant Guidewire, Brivant Limited (2006) Summary page 5.
- K040345: Modification to Nitrex Nitinol Guidewire, Ev3, Inc. (2004) Summary page 5.

## Most influential descendants
- K253746: Enroute 0.014'' Transcarotid Guidewire (2026), 0 descendants of its own

## Indications for use
The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature. Contraindications: ENROUTE 0.014" Guidewire is not intended for use in: - The cerebral or coronary vasculature - Patients judged not acceptable for percutaneous intervention

Source page: https://510kreport.com/device/K160643
Methodology: https://510kreport.com/methodology