Clearance Summary
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE received FDA 510(k) clearance under submission number K080821, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2008-04-22.
- Submission: K080821
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5730
- Decision date: 2008-04-22
Classification & Regulation
This clearance is catalogued under FDA product code BTR and 21 CFR 868.5730, within the Anesthesiology review panel as a Class II device.