Clearance Summary
WIRION Embolic Protection System received FDA 510(k) clearance under submission number K210282, sponsored by Cardiovascular Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-03-03.
- Submission: K210282
- Applicant / Sponsor: Cardiovascular Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2021-03-03
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.