# K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Ireland
- Decided: Oct 22, 2010 after 14 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.
13 later devices descend from it; 4 cite it directly.
0 of 15 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 2.

## Most influential descendants
- K112735: Tamarin Blue Ptca RX Dilatation Catheter (2012), 5 descendants of its own
- K160985: Pantera Pro (2016), 3 descendants of its own
- K163660: Pantera LEO (2017), 2 descendants of its own
- K131169: Mozec - RX Ptca Balloon Dilatation Catheter (2013), 2 descendants of its own
- K242969: Pantera Pro; Pantera LEO (2024), 1 descendant of its own

## 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.

Source page: https://510kreport.com/device/K103095
Methodology: https://510kreport.com/methodology