# K162434: NC Gallant PTCA Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medinol, Ltd.
- Decided: Jan 19, 2017 after 141 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: 2 generations back to P860019 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110134: NC Trek RX Coronary Dilatation Catheter, Abbott Vascular-Cardiac Therapies (2011) Summary page 4.
- K121667: NC Quantum Apex Ptca Dilatation Catheter (Monorail), Boston Scientific Corp (2012) Summary page 4.

## Most influential descendants
- K173581: Gallant PTCA Dilatation Catheter (2018), 0 descendants of its own

## Indications for use
The NC Gallant PTCA 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/K162434
Methodology: https://510kreport.com/methodology