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510(k) K221319

BD Alaris™ Pump Epidural Infusion Set by Care Fusion — Product Code PWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2023
Date Received
May 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Administrations Sets With Neuraxial Connectors
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.

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