Device Dossier

Double-ended handle sizer rings Model 905-15 - Cardiac valve prosthesis sizer set

Device Dossier for Double-ended handle sizer rings Model 905-15 - Cardiac valve prosthesis sizer set (Cardiac valve prosthesis sizer set, Class III,…

Intended purpose

The Double-ended Handle Sizer Ring Model 905-15 is intended to aid in the selection of the appropriate mechanical heart valve size. It is indicated to aid in the selection of the 15AHPJ‑505 and 15MHPJ‑505 valves for use in pediatric patients with a diseased, damaged, or malfunctioning aortic or mitral valve.

Functional description

The Double-ended handle sizer rings Model 905-15 may be used to facilitate proper valve size selection. The sizer handle may be bent in any direction up to a 90° angle without degradation. When the flexible handle is exposed to the heat produced during autoclave sterilization, it will revert to its original shape. The sizer is supplied non-sterile.

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