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