K261428
- 510(k) number
- K261428
- Device name
- NC Euphora Rapid Exchange Balloon Dilatation Catheter
- Applicant
- Medtronic Ireland IE
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2026-08-14
- Date received
- 2026-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K261428.pdf
Official FDA record: K261428
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.