# K173581: Gallant PTCA Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medinol, Ltd.
- Decided: Jan 25, 2018 after 66 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- 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 P860019 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162434: NC Gallant PTCA Catheter, Medinol, Ltd. (2017) Summary page 4.

## Indications for use
The Gallant PTCA Dilatation Catheter is indicated for: • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; • Post-deployment stent expansion.

Source page: https://510kreport.com/device/K173581
Methodology: https://510kreport.com/methodology