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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 K223101
Device Name BD Secondary Infusion Set
Applicant
Care Fusion
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Applicant Contact Paulina Davis
Correspondent
Care Fusion
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Correspondent Contact Paulina Davis
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/30/2022
Decision Date 05/12/2023
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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