Device Dossier
Epic™ Max Heart Valve Sizer Set - Cardiac valve prosthesis sizer set
Device Dossier for Epic™ Max Heart Valve Sizer Set - Cardiac valve prosthesis sizer set (Cardiac valve prosthesis sizer set, Class III, sponsor Abbott…
- GMDN category: Cardiac valve prosthesis sizer set
Intended purpose
The EMAX-1000 sizer sets are intended to aid in the selection of the appropriate Epic™ Max Tissue Valve size.
Functional description
The Epic™ Max Heart Valve Sizer Set Model EMAX‑1000 is a multicomponent kit that facilitates the size selection of the applicable Epic™ Max stented tissue valve. The EMAX‑1000 sizers and holder handle can be bent in any direction up to a 90° angle without degradation. When the flexible handles are exposed to the heat produced during autoclave sterilization, they will revert to their original shape.