Clearance Summary
TRIVEX SYSTEM received FDA 510(k) clearance under submission number K032387, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-10-29.
- Submission: K032387
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4885
- Decision date: 2003-10-29
Classification & Regulation
This clearance is catalogued under FDA product code DWQ and 21 CFR 870.4885, within the Cardiovascular review panel as a Class II device.