Device Dossier
SJM Tailor™ Annuloplasty Ring Sizer Set - Cardiac valve prosthesis sizer set
Device Dossier for SJM Tailor™ Annuloplasty Ring Sizer Set - Cardiac valve prosthesis sizer set (Cardiac valve prosthesis sizer set, Class III, sponsor…
- GMDN category: Cardiac valve prosthesis sizer set
Intended purpose
The Sizers are intended to aid in the selection of the appropriate SJM Tailor™ Annuloplasty Ring during implantation.
Functional description
The SJM Tailor™ Annuloplasty Ring Sizer Set, Model TAR-505, is a multi-component reusable kit to be used by the physician for determining the correct size SJM Tailor™ Annuloplasty 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.