Clearance Summary
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED received FDA 510(k) clearance under submission number K102618, sponsored by Draeger Medical AG & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2010-12-10.
- Submission: K102618
- Applicant / Sponsor: Draeger Medical AG & Co. KG
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2010-12-10
Classification & Regulation
This clearance is catalogued under FDA product code BTT and 21 CFR 868.5450, within the Anesthesiology review panel as a Class II device.