Clearance Summary
VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER received FDA 510(k) clearance under submission number K010485, sponsored by Bbraun. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-05-18.
- Submission: K010485
- Applicant / Sponsor: Bbraun
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3375
- Decision date: 2001-05-18
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.