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510(k) K250059

BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) by Becton, Dickinson and Company — Product Code ONB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
January 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

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