Clearance Summary
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE received FDA 510(k) clearance under submission number K131254, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-08-20.
- Submission: K131254
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5730
- Decision date: 2013-08-20
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.