Clearance Summary
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM received FDA 510(k) clearance under submission number K081523, sponsored by Abbott Vascular-Vascular Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-09-11.
- Submission: K081523
- Applicant / Sponsor: Abbott Vascular-Vascular Solutions
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2008-09-11
Classification & Regulation
This clearance is catalogued under FDA product code NTE and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.