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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K253048
Device Name High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
Applicant
Shenzhen Maiwei Biotech Co., Ltd.
2-10 Jinlong Blvd. S., Pingshan
Shenzhen,  CN 518118
Applicant Contact Woody Chen
Correspondent
Chonconn Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Jie Yang
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/22/2025
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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