Clearance Summary
VENA CAVA FILTER SYSTEMS, MODIFICATION received FDA 510(k) clearance under submission number K925679, sponsored by B. Braun Vena-Tech. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1992-11-27.
- Submission: K925679
- Applicant / Sponsor: B. Braun Vena-Tech
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3375
- Decision date: 1992-11-27
Classification & Regulation
This clearance is catalogued under FDA product code DTK and 21 CFR 870.3375, within the Cardiovascular review panel as a Class II device.