# K252317: Zenith Micro Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Zenith Vascular SciTech Limited
- Decided: Apr 16, 2026 after 265 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: 7 generations back to K002212 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133725: Traxcess 14 Guidewire, MicroVention, Inc. (2014) Summary page 5.
- K243938: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire, Scientia Vascular, Inc. (2025) Summary page 5.

## Indications for use
Zenith Micro Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

Source page: https://510kreport.com/device/K252317
Methodology: https://510kreport.com/methodology