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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K254248
Device Name Introducer Sheath Set
Applicant
Cardiocycle Medical(Suzhou) Co., Ltd.
Unit 401&501, Bldg. C15, Stage 5, Biobay
#21 Chaoqian Rd., Suzhou Industrial Park
Suzhou, Jiangsu,  CN 215000
Applicant Contact Siyu Chen
Correspondent
Cardiocycle Medical(Suzhou) Co., Ltd.
Unit 401&501, Bldg. C15, Stage 5, Biobay
#21 Chaoqian Rd., Suzhou Industrial Park
Suzhou, Jiangsu,  CN 215000
Correspondent Contact Siyu Chen
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/29/2025
Decision Date 04/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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