# K251970: Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Ireland
- Decided: Jan 17, 2026 after 205 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)
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 6.
- K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon, Medtronic, Ireland (2010) Summary page 6.

## Indications for use
The Sprinter Legend RX and OTW 1.25mm Balloon Dilatation Catheter is indicated as a pre dilatation catheter for enlarging coronary luminal diameters during PCI procedures. The Sprinter Legend RX 1.5-4.0mm 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 2.25 mm - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K251970
Methodology: https://510kreport.com/methodology