PST · Class II · 21 CFR 870.3800

FDA Product Code PST: Aortic Annuloplasty Ring

To Correct Annular Dilatation And/or Maintain Annular Geometry Of The Aortic Valve.

Leading manufacturers include Biostable Science & Engineering, Inc..

2
Total
2
Cleared
89d
Avg days
2017
Since

FDA 510(k) Cleared Aortic Annuloplasty Ring Devices (Product Code PST)

2 devices
1–2 of 2
Cleared Aug 10, 2017
HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm
K171431
Biostable Science & Engineering, Inc.
Cardiovascular · 87d
Cleared Mar 21, 2017
HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
K163608
Biostable Science & Engineering, Inc.
Cardiovascular · 90d

About Product Code PST - Regulatory Context