# K262424: Willow 12 Guidewire

- Pathway: 510(k) (Special)
- Applicant: Arbor Endovascular, LLC
- Decided: Aug 14, 2026 after 29 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). 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)
- K253168: 0.014” Willow Guidewire, Arbor Endovascular, LLC (2025) Summary page 5.

## Indications for use
The Willow 12 Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Source page: https://510kreport.com/device/K262424
Methodology: https://510kreport.com/methodology