NKM

Mitral Valve Repair Devices

Product code
NKM
Device name
Mitral Valve Repair Devices
Device class
Class 3
Medical specialty
Unknown
Marketing pathway
PMA
Flag
Implant

FDA classification definition

To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.

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

Official FDA classification page: NKM
Classification and pathway per current FDA publications. Data from openFDA (CC0).