Clearance Summary
DRAGON HEART I.V. SET received FDA 510(k) clearance under submission number K043235, sponsored by Dragon Heart Medical Devices Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-03-08.
- Submission: K043235
- Applicant / Sponsor: Dragon Heart Medical Devices Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2005-03-08
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.