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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 K211393
Device Name Selethru(TM) NC PTCA Balloon Dilatation Catheter
Applicant
Kossel Medtech (Suzhou) Co., Ltd.
F2-3, BLDG 6, No. 8, Jinfeng Road, Suzhou New District
Suzhou,  CN 215163
Applicant Contact Maggie Xu
Correspondent
Kossel Medtech (Suzhou) Co., Ltd.
F2-3, BLDG 6, No. 8, Jinfeng Road, Suzhou New District
Suzhou,  CN 215163
Correspondent Contact Maggie Xu
Regulation Number870.5100
Classification Product Code
LOX  
Date Received05/05/2021
Decision Date 07/02/2021
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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