Clearance Summary
Q-FLO CLOSED MALE LUER CONNECTOR received FDA 510(k) clearance under submission number K121554, sponsored by Us Fusion, LLC. Dba Truecare Biomedix-USA. 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 2012-06-08.
- Submission: K121554
- Applicant / Sponsor: Us Fusion, LLC. Dba Truecare Biomedix-USA
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2012-06-08
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.