# K222437: Aristotle Colossus Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Scientia Vascular, Inc.
- Decided: Jan 26, 2023 after 167 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- 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: 5 generations back to K002212 (2000). 5 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192783: Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile, Scientia Vascular, LLC (2019) Summary page 4.

## Most influential descendants
- K243938: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire (2025), 2 descendants of its own
- K254181: Aristotle 65 Macrowire (2026), 0 descendants of its own
- K260751: 35 Helix Guidewire (2026), 0 descendants of its own
- K260223: Aristotle Mini Guidewire (2026), 0 descendants of its own
- K252317: Zenith Micro Guidewire (2026), 0 descendants of its own

## Indications for use
The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

Source page: https://510kreport.com/device/K222437
Methodology: https://510kreport.com/methodology