Clearance Summary
Huber Needle Infusion Set, Safety Huber Needle Infusion Set received FDA 510(k) clearance under submission number K200463, sponsored by Jiangsu Caina Medical 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 2021-04-07.
- Submission: K200463
- Applicant / Sponsor: Jiangsu Caina Medical Co.,Ltd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2021-04-07
Classification & Regulation
This clearance is catalogued under FDA product code PTI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.