# K141054: Distal Access Torque Device

- Pathway: 510(k) (Traditional)
- Applicant: Distal Access, LLC
- Decided: Dec 10, 2014 after 236 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 K854261 (1985). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936032: Torque Device, Merit Medical Systems, Inc. (1994) Summary page 4.
- K100093: Vsi Torque Device, Vascular Solutions, Inc. (2010) Summary page 4.

## Most influential descendants
- K170684: Firebow Wire Torque Assist Device (2017), 1 descendant of its own
- K221917: Stent Positioning Assistance System (SPAS) (2022), 0 descendants of its own
- K200120: LiteSaber Wire Torque Assist Device (2020), 0 descendants of its own

## Indications for use
Distal Access torque devices are used to maneuver guide wires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature.

Source page: https://510kreport.com/device/K141054
Methodology: https://510kreport.com/methodology