K261759
- 510(k) number
- K261759
- Device name
- Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
- Applicant
- Medtronic Ireland IE
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2026-07-27
- Date received
- 2026-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K261759.pdf
Official FDA record: K261759
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.