Clearance Summary
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 received FDA 510(k) clearance under submission number K001872, sponsored by Codan US Corp.. 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 2000-09-07.
- Submission: K001872
- Applicant / Sponsor: Codan US Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2000-09-07
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.