Device Dossier

Regent™ Mechanical Heart Valve Sizer Set - Cardiac valve prosthesis sizer set

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

Intended purpose

The Regent™ Mechanical Heart Valve Sizers are intended to aid in the selection of the appropriate mechanical heart valve size.

Functional description

The Regent™ Mechanical Heart Valve Sizer Set Model 907 is a kit comprised of multiple sizing tools that facilitate proper handling and implant size selection of the Regent™ Mechanical Heart Valve. The Model 907 sizers are double-ended tools with a cylindrical valve sizing end, and a Regent™ valve replica end. The sizer handles can be bent in any direction up to a 90° angle without degradation.

TGA Public Summary