# K170684: Firebow Wire Torque Assist Device

- Pathway: 510(k) (Traditional)
- Applicant: Vesatek, LLC
- Decided: Jun 29, 2017 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: 8 generations back to K854261 (1985). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141054: Distal Access Torque Device, Distal Access, LLC (2014) Summary page 4.
- K936032: Torque Device, Merit Medical Systems, Inc. (1994) Summary page 4.

## Most influential descendants
- K200120: LiteSaber Wire Torque Assist Device (2020), 0 descendants of its own

## Indications for use
The Firebow Wire Torque Assist Device is used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. The Firebow Wire Torque Assist Device is not intended for use in the neurovasculature.

Source page: https://510kreport.com/device/K170684
Methodology: https://510kreport.com/methodology