Clearance Summary
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT received FDA 510(k) clearance under submission number K012584, sponsored by Bd. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-09-06.
- Submission: K012584
- Applicant / Sponsor: Bd
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 2001-09-06
Classification & Regulation
This clearance is catalogued under FDA product code CAZ and 21 CFR 868.5140, within the Anesthesiology review panel as a Class II device.