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510(k) K240146

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

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

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  • K100402 — SITE-RITE VISION ULTRASOUND SYSTEM (March 5, 2010)
  • K071095 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 18, 2007)

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