Device type
Prosthesis, Mitral Valve, Percutaneously Delivered
Product code NPU · Class III · Unknown
These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Recent 510(k)s
No 510(k) clearances in the archive for NPU.
Recent recalls
Nov 2, 2026
Z-0287-2027
Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/Catalog Number: 9880CM29A Software Version: Not appli…
Edwards Lifesciences, LLC
- NPU
- Class III
- Open, Classified