Clearance Summary
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE received FDA 510(k) clearance under submission number K030570, 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 2003-09-17.
- Submission: K030570
- Applicant / Sponsor: Portex , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 2003-09-17
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.