# K193194: CrossTorq 14 Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Scientia Cardio Access, LLC
- Decided: Dec 13, 2019 after 24 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 K913353 (1991). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081021: Kinetix Guidewire, Plus Guidewire, Boston Scientific Corp (2008) Summary page 5.
- K152231: Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire, Boston Scientific Corporation (2016) Summary page 5.

## Indications for use
The CrossTorqTM 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorqTM 14 Guidewire is not intended for use in the neurovasculature.

Source page: https://510kreport.com/device/K193194
Methodology: https://510kreport.com/methodology