PST

Aortic Annuloplasty Ring

Product code

PST

Device name

Aortic Annuloplasty Ring

Device class

Class 2

21 CFR

21 CFR 870.3800

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Implant

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

To correct annular dilatation and/or maintain annular geometry of the aortic valve.

Definition text from the FDA device classification database (U.S. federal government work, public domain).