BD Prevue II Peripheral Vascular Vascular Access System

System, Imaging, Pulsed Echo, Ultrasonic

Bard Access Systems, Inc, (C.R. Bard, Inc.)

The following data is part of a premarket notification filed by Bard Access Systems, Inc, (c.r. Bard, Inc.) with the FDA for Bd Prevue Ii Peripheral Vascular Vascular Access System.

Pre-market Notification Details

Device IDK211193
510k NumberK211193
Device Name:BD Prevue II Peripheral Vascular Vascular Access System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Bard Access Systems, Inc, (C.R. Bard, Inc.) 605 North 5600 West Salt Lake City,  UT  84116
ContactFabio De Pasquale
CorrespondentFabio De Pasquale
Bard Access Systems, Inc, (C.R. Bard, Inc.) 605 North 5600 West Salt Lake City,  UT  84116
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeLLZ
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-21
Decision Date2021-06-25

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