510(k) K223198

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) by Bard Access Systems — Product Code MHC

K223198 is an FDA 510(k) premarket notification submitted by Bard Access Systems for the device "BD Intraosseous Vascular Access System EMS Powered Driver (D001003)". The FDA issued a decision of Substantially Equivalent on November 10, 2022. The device falls under product code MHC (Needle, Interosseous), a Class II device regulated under 21 CFR 880.5570. Bard Access Systems has at least 10 other 510(k) clearances on record.