Clearance Summary
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA received FDA 510(k) clearance under submission number K101721, sponsored by Regulatory and Marketing Services, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2011-03-24.
- Submission: K101721
- Applicant / Sponsor: Regulatory and Marketing Services, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 2011-03-24
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.