# K260751: 35 Helix Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Piraeus Medical, Inc.
- Decided: Aug 27, 2026 after 174 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222437: Aristotle Colossus Guidewire, Scientia Vascular, Inc. (2023) Summary page 5.

## Indications for use
The 35 Helix 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/K260751
Methodology: https://510kreport.com/methodology