Ryurei— 510(k) K252295
Substantially EquivalentTerumo Corporation
FDA 510(k) clearance K252295 for Ryurei, Substantially Equivalent on 2026-03-27. Applicant: Terumo Corporation. Device class: 2.
Summary
Terumo's Ryurei is filed under LOX, percutaneous transluminal coronary angioplasty catheters. The record gives only that one-word name, with no sizes or models.
Class II, 21 CFR 870.5100. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Terumo filed from Tokyo, Japan. Review took 247 calendar days (July 23, 2025 to March 27, 2026).
Clearance details
- Applicant
- Terumo Corporation
- Product code
- Product code LOX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code LOX
view allMore clearances from Terumo Corporation
view allAdverse events under product code LOX
product code LOX- Death
- 190
- Injury
- 1,498
- Malfunction
- 9,670
- Total
- 11,358
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.