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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K230528
Device Name Extension Set
Applicant
Medcaptain Life Science Co., Ltd.
601, Bldg. C, Jinweiyuan Industrial Park, Pingshan
District
Shenzhen,  CN 518118
Applicant Contact Alan Tao
Correspondent
Medcaptain Life Science Co., Ltd.
601, Bldg. C, Jinweiyuan Industrial Park, Pingshan
District
Shenzhen,  CN 518118
Correspondent Contact Alan Tao
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/27/2023
Decision Date 12/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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