Clearance Summary
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) received FDA 510(k) clearance under submission number K032112, sponsored by Portex , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2004-01-26.
- Submission: K032112
- Applicant / Sponsor: Portex , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5730
- Decision date: 2004-01-26
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.