510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NKMClass III

Mitral Valve Repair Devices

Unknown
FDA source (opens on fda.gov)

NKM is the FDA product code for Mitral Valve Repair Devices, a class III device type. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 6 recalls.

Classification record

Product code
NKM
Device name
Mitral Valve Repair Devices
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order