510(k) K211193

BD Prevue II Peripheral Vascular Vascular Access System by Bard Access Systems, Inc. (C.R. Bard, Inc.) — Product Code IYO

K211193 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. (C.R. Bard, Inc.) for the device "BD Prevue II Peripheral Vascular Vascular Access System". The FDA issued a decision of Substantially Equivalent on Jun 25, 2021. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Bard Access Systems, Inc. (C.R. Bard, Inc.) has at least 2 other 510(k) clearances on record.