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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Interosseous
510(k) Number K203193
Device Name BD Intraosseous Infusion System
Applicant
Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Connor Dahl
Correspondent
Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Connor Dahl
Regulation Number880.5570
Classification Product Code
MHC  
Date Received10/28/2020
Decision Date 03/04/2021
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
Recalls CDRH Recalls
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