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510(k) K203193

BD Intraosseous Infusion System by Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] — Product Code MHC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 4, 2021
Date Received: October 28, 2020
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Needle, Interosseous
Device Class: Class II
Regulation Number: 880.5570
Review Panel: HO
Submission Type