Clearance Summary
ENDOLUMINAL OCCLUSION SYSTEM (EOS) received FDA 510(k) clearance under submission number K133924, sponsored by Artventive Medical Group, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-12-03.
- Submission: K133924
- Applicant / Sponsor: Artventive Medical Group, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3300
- Decision date: 2014-12-03
Classification & Regulation
This clearance is catalogued under FDA product code KRD and 21 CFR 870.3300, within the Cardiovascular review panel as a Class II device.