Clearance Summary
BD Prevue II Peripheral Vascular Access System received FDA 510(k) clearance under submission number K240146, sponsored by Bard Access Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-02-18.
- Submission: K240146
- Applicant / Sponsor: Bard Access Systems, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2024-02-18
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.