# K244061: X-Wire Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Imperative Care, Inc.
- Decided: Aug 26, 2025 after 238 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231954: Aristotle 18 Guidewire; Aristotle 24 Guidewire, Scientia Vascular, Inc. (2023) Summary page 5.
- K220398: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire, Scientia Vascular, LLC (2023) Summary page 5.

## Indications for use
The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature 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/K244061
Methodology: https://510kreport.com/methodology