Clearance Summary
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER received FDA 510(k) clearance under submission number K091670, sponsored by Becton, Dickinson & CO. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-07-01.
- Submission: K091670
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2009-07-01
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.