Clearance Summary
CardiaMend Pericardial and Epicardial Reconstruction Matrix received FDA 510(k) clearance under submission number K210331, sponsored by Helios Cardio, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-12-21.
- Submission: K210331
- Applicant / Sponsor: Helios Cardio, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2021-12-21
Classification & Regulation
This clearance is catalogued under FDA product code PSQ and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.