510(k) K240146

BD Prevue™ II Peripheral Vascular Access System by Bard Access Systems, Inc. — Product Code IYO

K240146 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "BD Prevue™ II Peripheral Vascular Access System". The FDA issued a decision of Substantially Equivalent on February 18, 2024. 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. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2024
Date Received
January 19, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type