# K042373: Galeo Focus Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Mar 2, 2005 after 182 days
- Product code: DQX (Wire, Guide, Catheter)
- 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: 4 generations back to K913353 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982272: Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo F 014 Model 115 487 Galeo HF 018, Biotronik, Inc. (1999) Summary page 1.
- K001736: Galeo Hydro and Galeo Hydro J-Tip, Biotronik, Inc. (2000) Summary page 1.

## Indications for use
Galeo coronary guide wires are indicated to facilitate the placement of balloon dilation catheters or other interventional devices with compatible guide wire lumen during an interventional procedure.

Source page: https://510kreport.com/device/K042373
Methodology: https://510kreport.com/methodology