Clearance Summary
CRUX VENA CAVA FILTER SYSTEM received FDA 510(k) clearance under submission number K122585, sponsored by Crux Biomedical. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-01-17.
- Submission: K122585
- Applicant / Sponsor: Crux Biomedical
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3375
- Decision date: 2013-01-17
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.