# K100093: Vsi Torque Device

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Apr 30, 2010 after 107 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 K854261 (1985). 14 ancestors in all.
4 later devices descend 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)
- K032411: JS Vascular Guide Wire Vise/Torque Device, Js Vascular, Inc. (2003)
- K021243: Ilt Torquer, Model 114TR1, Intra Luminal Therapeutics, Inc. (2002) Summary page 1.
- K092711: Guardian II Hemostasis Valve, Zerusa Limited (2009)

## Most influential descendants
- K141054: Distal Access Torque Device (2014), 3 descendants of its own
- 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
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.

Source page: https://510kreport.com/device/K100093
Methodology: https://510kreport.com/methodology