# 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

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jan 8, 1999 after 193 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: 3 generations back to K913353 (1991). 6 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K973494: HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance Middleweight Guide Wire with Hydg, Guidant Corp. (1997) Summary page 2.
- K961917: Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX), Medtronics Interventional Vascular (1996) Summary page 2.

## Most influential descendants
- K090193: Conductor Coronary Guidewire (2009), 0 descendants of its own
- K042373: Galeo Focus Guide Wire (2005), 0 descendants of its own

## Indications for use
Galeo Guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.

Source page: https://510kreport.com/device/K982272
Methodology: https://510kreport.com/methodology