Clearance Summary
BECTON DICKINSON INTELLIPORT SYSTEM received FDA 510(k) clearance under submission number K141474, sponsored by Becton, Dickinson & CO. 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 2014-12-18.
- Submission: K141474
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2014-12-18
Classification & Regulation
This clearance is catalogued under FDA product code PHC and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.