Device Dossier

Rigid Saddle Ring Sizer Set - Cardiac valve prosthesis sizer set

Device Dossier for Rigid Saddle Ring Sizer Set - Cardiac valve prosthesis sizer set (Cardiac valve prosthesis sizer set, Class III, sponsor Abbott…

Intended purpose

The Rigid Saddle Ring Sizers are intended to aid in the selection of the appropriate Rigid Saddle Ring during implantation.

Functional description

The Rigid Saddle Ring Sizer Set, Model RSAR‑507A, is a multi‑component reusable kit to be used by the physician for determining the correct size Rigid Saddle Ring. The sizer set contains six Sizers, one Holder Handle, and one Extension Handle. The sizer set is provided non‑sterile in a covered tray for storage and is indicated for use after appropriate cleaning and sterilization. The Sizers are used to facilitate proper sizing of the valve annulus and selection of the annuloplasty ring.

TGA Public Summary