Clearance Summary
REGENSIS PERICARDIAL PATCH received FDA 510(k) clearance under submission number K051405, sponsored by Cormatrix Cardiovascular, 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 2005-08-31.
- Submission: K051405
- Applicant / Sponsor: Cormatrix Cardiovascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2005-08-31
Classification & Regulation
This clearance is catalogued under FDA product code DXZ and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.