Device Dossier

Perceval Set (ICV1219) - Cardiac valve prosthesis sizer set

Device Dossier for Perceval Set (ICV1219) - Cardiac valve prosthesis sizer set (Cardiac valve prosthesis sizer set, Class III, sponsor BTC Cardio). ARTG…

Intended purpose

The Sizer Set is intended to be used to assist the cardiac surgeon in choosing the correct size of Perceval Plus Prosthesis.

Functional description

The sizers are designed to assist the physician in choosing the correct size for the associated prosthesis. Each sizer has a transparent obturator and a white obturator. The transparent obturator represents the lower limit, and the white obturator represents the upper limit of the aortic annular diameter range associated with each prosthesis valve.”

TGA Public Summary