Clearance Summary
U & U Intravascular Administration Set received FDA 510(k) clearance under submission number K151151, sponsored by U&U Medical Technology Co, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2015-09-24.
- Submission: K151151
- Applicant / Sponsor: U&U Medical Technology Co, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2015-09-24
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.