Device Dossier

Mechanical Heart Valve Sizer Set - Cardiac valve prosthesis sizer set

Device Dossier for Mechanical Heart Valve Sizer Set - Cardiac valve prosthesis sizer set (Cardiac valve prosthesis sizer set, Class III, sponsor Abbott…

Intended purpose

The Valve Sizers (model 905) are intended to aid in the selection of the appropriate mechanical heart valve size.

Functional description

The Sizer Set Model 905 contains double-ended and single-ended sizing tools for measuring the diameter of the valve annulus prior to selection of a corresponding sized Abbott Mechanical Heart Valve (MHV). The double-ended tools have a supra-annular sizer ring at one end and an intra-annular sizer ring at the other end. The single-ended sizing tools have intra-annular sizing rings. In addition, the set contains a holder handle with a flexible tip for connecting to a mechanical heart valve holder.

TGA Public Summary