# K261759: Euphora Rapid Exchange (RX) Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Ireland
- Decided: Jul 27, 2026 after 60 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 P790017 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143480: Euphora Rapid Exchange Balloon Dilatation Catheter, Medtronic, Inc. (2015) Summary page 6.

## Indications for use
The 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 (balloon models 2.00 mm to 4.00 mm) is also indicated for postdeployment expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K261759
Methodology: https://510kreport.com/methodology