K251970
- 510(k) number
- K251970
- Device name
- Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
- Applicant
- Medtronic, Ireland IE
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2026-01-17
- Date received
- 2025-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251970.pdf
Official FDA record: K251970
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.