Medtronic, Ireland · Class II · Cleared Jan 17, 2026
| K-number | K251970 |
| Device name | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter |
| Applicant | Medtronic, Ireland |
| Product code | LOX |
| Device class | Class II |
| Decision date | Jan 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.5100 |
The Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is a percutaneous transluminal coronary angioplasty (PTCA) device used to dilate stenotic coronary arteries and bypass graft stenosis to improve blood flow. The 1.25mm size is indicated for pre-dilatation, while 1.5-4.0mm sizes are indicated for primary dilatation and post-delivery expansion of balloon expandable stents.
The device comprises a proximal luer hub assembly with hypotube and stiffening wire, and a distal end with an inflatable balloon, dual lumen tip (for guidewire and inflation), and radiopaque marker bands. The distal shaft includes a hydrophilic coating and accommodates a 0.014" guidewire. The primary difference from the predicate is a material change; however, sterilization, sterility assurance level, and shelf life remain unchanged.
Biocompatibility testing was conducted per ISO 10993 standards, including chemical characterization, toxicological risk assessment, cytotoxicity, acute systemic toxicity, hemocompatibility (hemolysis, complement activation, PTT, platelet/leucocyte count), sensitization, irritation, and material-mediated pyrogenicity.
The subject device is substantially equivalent to Medtronic's own predicate device (Sprinter Legend RX) because it demonstrates comparable safety and performance through comprehensive bench testing. All test results met acceptance criteria consistent with the predicate, and the material difference does not introduce different questions of safety or effectiveness. No clinical testing was required.
View the full FDA submission: accessdata.fda.gov