Clearance Summary
E-VAX CHEST DRAINAGE SYSTEM received FDA 510(k) clearance under submission number K801043, sponsored by Cardio Surgical Concepts, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1980-06-20.
- Submission: K801043
- Applicant / Sponsor: Cardio Surgical Concepts, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1980-06-20
Classification & Regulation
This clearance is catalogued under FDA product code JCX and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.