BD Prevue II Peripheral Vascular Access System
FDA 510(k) K240146 · Bard Access Systems, Inc.
510(k) numberK240146
Submission
- Device name
- BD Prevue II Peripheral Vascular Access System
- Applicant
- Bard Access Systems, Inc.
Salt Lake City, UT, US - Received
- January 19, 2024
- Decision date
- February 18, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was BD Prevue II Peripheral Vascular Access System cleared by the FDA?
BD Prevue II Peripheral Vascular Access System (K240146) received a 510(k) decision of Substantially Equivalent on February 18, 2024, 30 days after the submission was received.
What is the product code of K240146?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.