# K243938: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire

- Pathway: 510(k) (Special)
- Applicant: Scientia Vascular, Inc.
- Decided: Apr 1, 2025 after 102 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: 6 generations back to K002212 (2000). 8 ancestors in all.
2 later devices descend from it; 2 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)
- K173235: Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile, Scientia Vascular, LLC (2018) Summary page 6.
- K231954: Aristotle 18 Guidewire; Aristotle 24 Guidewire, Scientia Vascular, Inc. (2023) Summary page 6.
- K201760: Zoom 14 Guidewire, Scientia Vascular, LLC (2020) Summary page 6.
- K222437: Aristotle Colossus Guidewire, Scientia Vascular, Inc. (2023) Summary page 6.

## Most influential descendants
- 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 14 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. The Aristotle 18 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. The Aristotle 24 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. The Zoom Wire 14 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. 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/K243938
Methodology: https://510kreport.com/methodology