Clearance Summary
TRACHEOSTOMY TUBE AND CUFF received FDA 510(k) clearance under submission number K912124, sponsored by Concord/Portex. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1991-08-16.
- Submission: K912124
- Applicant / Sponsor: Concord/Portex
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1991-08-16
Classification & Regulation
This clearance is catalogued under FDA product code BTO and 21 CFR 868.5800, within the Anesthesiology review panel as a Class II device.