Clearance Summary
HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm received FDA 510(k) clearance under submission number K163608, sponsored by Biostable Science & Engineering, 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 2017-03-21.
- Submission: K163608
- Applicant / Sponsor: Biostable Science & Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3800
- Decision date: 2017-03-21
Classification & Regulation
This clearance is catalogued under FDA product code PST and 21 CFR 870.3800, within the Cardiovascular review panel as a Class II device.