PSTClass IIImplantLife-sustaining
Aortic Annuloplasty Ring
Cardiovascular · 21 CFR 870.3800
To correct annular dilatation and/or maintain annular geometry of the aortic valve.
MDR events1All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances2All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
510(k) clearances
2 clearances for this product code
- Biostable Science & Engineering, Inc.Aug 10, 2017
K171431 · HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm
- Biostable Science & Engineering, Inc.Mar 21, 2017
K163608 · HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm