Clearance Summary
MICRODOSE CATH, MODELS 90121-201, -202, -203 received FDA 510(k) clearance under submission number K011383, sponsored by Durect Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2001-06-25.
- Submission: K011383
- Applicant / Sponsor: Durect Corp.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3880
- Decision date: 2001-06-25
Classification & Regulation
This clearance is catalogued under FDA product code ETD and 21 CFR 874.3880, within the Ear, Nose, Throat review panel as a Class II device.