# K182337: HYBRID Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Balt USA, LLC
- Decided: Oct 4, 2018 after 37 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: 5 generations back to K953533 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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 4.

## Most influential descendants
- K252011: CHIKAI Nexus petit (2026), 0 descendants of its own

## Indications for use
The HYBRID Guidewire is intended 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 the coronary arteries.

Source page: https://510kreport.com/device/K182337
Methodology: https://510kreport.com/methodology