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510(k) K250325

BD Alaris Pump Infusion Set by Carefusion (Bd) — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
February 5, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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