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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K231888
Device Name BD Texium™ Needle-Free Syringe
Applicant
Care Fusion
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Applicant Contact Breanna Casados
Correspondent
Care Fusion
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Correspondent Contact Breanna Casados
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
ONB  
Date Received06/27/2023
Decision Date 09/25/2023
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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