# K253579: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Scientia Vascular, Inc.
- Decided: Apr 29, 2026 after 163 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
Aristotle 14 Guidewire 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. Aristotle 18 Guidewire 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. Aristotle 24 Guidewire 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. Zoom Wire 14 Guidewire 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.

Source page: https://510kreport.com/device/K253579
Methodology: https://510kreport.com/methodology