Ryurei
FDA 510(k) clearance K252295 · decided 2026-03-27
Clearance details
- K-number
- K252295
- Device name
- Ryurei
- Applicant
- Terumo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-07-23
- Decision date
- 2026-03-27
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- LOX
- Device class
- 2
- Regulation number
- 870.5100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.