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510(k) K223198

Device
BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
Applicant
Bard Access Systems
510(k) number
K223198
Product code
MHC  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-10
Date received
2022-10-13
Regulation
880.5570
Classification name
Needle, Interosseous
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nasreen Al-Quaid
Address
605 N. 5600 W. Salt Lake Ciy, UT US 84116 84116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MHC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203193BD Intraosseous Infusion SystemBard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]2021-03-04

Legacy Summary#

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FDA Review#

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