# K141090: NC Euphora Rapid Exchange Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Aug 15, 2014 after 109 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: 1 generation back to P790017 (1980). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 5.

## Most influential descendants
- K261428: NC Euphora Rapid Exchange Balloon Dilatation Catheter (2026), 0 descendants of its own
- K212393: OPN NC PTCA Dilatation Catheter (2022), 0 descendants of its own

## Indications for use
The NC Euphora™ Rapid Exchange Balloon 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. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K141090
Methodology: https://510kreport.com/methodology