Clearance Summary
Sterile Single-use Infusion Set received FDA 510(k) clearance under submission number K163160, sponsored by Jiangxi Hongda Medical Equipment Group , 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 2017-04-20.
- Submission: K163160
- Applicant / Sponsor: Jiangxi Hongda Medical Equipment Group , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2017-04-20
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.