Clearance Summary
Mi-CHORD System received FDA 510(k) clearance under submission number DEN230069, sponsored by Lsi Solutions, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-06-11.
- Submission: DEN230069
- Applicant / Sponsor: Lsi Solutions, Inc.
- Clearance pathway: Direct
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3490
- Decision date: 2024-06-11
Classification & Regulation
This clearance is catalogued under FDA product code SBK and 21 CFR 870.3490, within the Cardiovascular review panel as a Class II device.