Clearance Summary
SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT received FDA 510(k) clearance under submission number K874450, sponsored by Surgitech C/O Collier, Shannon, Rill & Scott. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1988-02-29.
- Submission: K874450
- Applicant / Sponsor: Surgitech C/O Collier, Shannon, Rill & Scott
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1988-02-29
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.