Clearance Summary
BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET received FDA 510(k) clearance under submission number K905518, sponsored by Venusa , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-06-21.
- Submission: K905518
- Applicant / Sponsor: Venusa , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 1991-06-21
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.