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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 K223022
Device Name SC HONKYTONK PTCA Balloon Dilatation Catheter
Applicant
Sino Medical Sciences Technology, Inc.
Teda Biopharm Research, #5, 4th St., Teda
Tianjin,  CN 300457
Applicant Contact Jianhua Sun
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr., #254
Suite 254
Annapolis,  MD  21401
Correspondent Contact Semih Oktay
Regulation Number870.5100
Classification Product Code
LOX  
Date Received09/29/2022
Decision Date 02/15/2023
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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