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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K252295
Device Name Ryurei
Applicant
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku
Tokyo,  JP 151-0072
Applicant Contact Kirsten Steinmann
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact Kirsten Steinmann
Regulation Number870.5100
Classification Product Code
LOX  
Date Received07/23/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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