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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
510(k) Number K250059
Device Name BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact Melissa Iwu
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact Melissa Iwu
Regulation Number880.5440
Classification Product Code
ONB  
Date Received01/10/2025
Decision Date 09/12/2025
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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