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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 K262674
Device Name Giranel Guiding Sheath Set
Applicant
Kossel Medtech (Suzhou) Co., Ltd.
Bldg. 6, # 8 Jinfeng Rd.
Suzhou New District,  CN 215163
Applicant Contact Sean Zhou
Correspondent
Kossel Medtech (Suzhou) Co., Ltd.
Bldg. 6, # 8 Jinfeng Rd.
Suzhou New District,  CN 215163
Correspondent Contact Sean Zhou
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/30/2026
Decision Date 10/15/2026
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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