Clearance Summary
GORE(R) EMBOLIC FILTER received FDA 510(k) clearance under submission number K120480, sponsored by W.L. Gore & Associates. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-03-16.
- Submission: K120480
- Applicant / Sponsor: W.L. Gore & Associates
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2012-03-16
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.