Clearance Summary
VACUUM ASSIST STABILIZER received FDA 510(k) clearance under submission number K992833, sponsored by Cardio Thoracic Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-11-10.
- Submission: K992833
- Applicant / Sponsor: Cardio Thoracic Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1999-11-10
Classification & Regulation
This clearance is catalogued under FDA product code MWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.