K252295
- 510(k) number
- K252295
- Device name
- Ryurei
- Applicant
- Terumo Corporation JP
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2026-03-27
- Date received
- 2025-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K252295.pdf
Official FDA record: K252295
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.