Clearance Summary
TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET received FDA 510(k) clearance under submission number K111351, sponsored by Us Infusion Dba Truecare Biomedix. 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 2011-09-29.
- Submission: K111351
- Applicant / Sponsor: Us Infusion Dba Truecare Biomedix
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2011-09-29
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.