Clearance Summary
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE received FDA 510(k) clearance under submission number K120443, sponsored by Baxter Healthcare Corporation - Renal Division. 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 2012-05-22.
- Submission: K120443
- Applicant / Sponsor: Baxter Healthcare Corporation - Renal Division
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2012-05-22
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.