Clearance Summary
CardioCel 3D received FDA 510(k) clearance under submission number K170951, sponsored by Admedus Regen Pty, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-04-28.
- Submission: K170951
- Applicant / Sponsor: Admedus Regen Pty, Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2017-04-28
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.