BD Intraosseous Vascular Access System EMS Powered Driver (D001003)— 510(k) K223198

Name: FDA 510(k) clearance K223198
Creator: U.S. Food and Drug Administration
Published: 2022-11-10

Substantially Equivalent

Bard Access Systems

FDA 510(k) clearance K223198 for BD Intraosseous Vascular Access System EMS Powered Driver (D001003), Substantially Equivalent on 2022-11-10. Applicant: Bard Access Systems. Device class: 2.

Clearance details

Applicant: Bard Access Systems
Product code: Code MHC
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2022-10-13
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

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