BD Intraosseous Vascular Access System EMS Powered Driver (D001003)

Needle, Interosseous

Bard Access Systems

The following data is part of a premarket notification filed by Bard Access Systems with the FDA for Bd Intraosseous Vascular Access System Ems Powered Driver (d001003).

Pre-market Notification Details

Device IDK223198
510k NumberK223198
Device Name:BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
ClassificationNeedle, Interosseous
Applicant Bard Access Systems 605 North 5600 West Salt Lake City,  UT  84116
ContactNasreen Al-Quaid
CorrespondentNasreen Al-Quaid
Bard Access Systems 605 North 5600 West Salt Lake City,  UT  84116
Product CodeMHC  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-10-13
Decision Date2022-11-10

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