Clearance Summary
D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES received FDA 510(k) clearance under submission number K101368, sponsored by Dragon Heart Medical, Inc.. 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 2010-11-18.
- Submission: K101368
- Applicant / Sponsor: Dragon Heart Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2010-11-18
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.