Clearance Summary
HERO GRAFT received FDA 510(k) clearance under submission number K124039, sponsored by Hemoshpere, Inc., A Cryolife Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-03-07.
- Submission: K124039
- Applicant / Sponsor: Hemoshpere, Inc., A Cryolife Company
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2013-03-07
Classification & Regulation
This clearance is catalogued under FDA product code DSY and 21 CFR 870.3450, within the Cardiovascular review panel as a Class II device.