# K143480: Euphora Rapid Exchange Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Apr 2, 2015 after 115 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: 3 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 5 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 6.

## Most influential descendants
- K163372: RX Takeru Balloon Dilatation Catheter (2017), 1 descendant of its own
- K261759: Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (2026), 0 descendants of its own
- K172264: OTW Takeru PTCA Balloon Dilatation Catheter (2018), 0 descendants of its own

## Recalls of this device
- Sep 3, 2019 · Class II · Z-0122-2020: Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
- Jul 13, 2017 · Class II · Z-3137-2017: Stylette removal difficulties on the Euphora and Solarice products.
- Jul 13, 2017 · Class II · Z-3136-2017: Stylette removal difficulties on the Euphora and Solarice products.

## Indications for use
The Euphora™ RX 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 2.00mm to 4.00mm) is also indicated for post deployment expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K143480
Methodology: https://510kreport.com/methodology