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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 K230992
Device Name DJF Intravascular Administration Set
Applicant
Yangzhou Wei De Li Trade Co. Ltd
Room 2412, Bldg.5, Cai Fu Plaza, 287 Yangzijiang Middle Road
Yangzhou,  CN 225000
Applicant Contact Joyce Wu
Correspondent
Vesco Devices
541 Lakewood Drive
Fairview,  TX  75069
Correspondent Contact Aaron Compton
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/06/2023
Decision Date 06/09/2023
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
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