Mitral Valve Repair Devices
The Mitral Valve Repair Device is an implantable cardiovascular device intended to repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation, differing from classified annuloplasty rings in that it does not require a cardiotomy and may be placed percutaneously. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NKM in the Cardiovascular review panel (no regulation number assigned). The device is flagged as an implant but is not life-sustaining.
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Basic Information
- Product Code
- NKM
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.