NKM · Mitral Valve Repair Devices
· Class 3
Overview
| Product Code | NKM |
|---|---|
| Device Name | Mitral Valve Repair Devices |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P220003 | PASCAL Precision Transcatheter Valve Repair System | Edwards Lifesciences, LLC | Sep 14, 2022 | APPR |
| P100009 | MITRACLIP DELIVERY SYSTEM | ABBOTT MEDICAL | Oct 24, 2013 | APPR |
Top Applicants
- ABBOTT MEDICAL — 1 clearance
- Edwards Lifesciences, LLC — 1 clearance
