Device Dossier

BRK Transseptal Needles - Needle, catheter

Device Dossier for BRK Transseptal Needles - Needle, catheter (Needle, catheter, Class III, sponsor Abbott Medical). ARTG record, intended purpose, GMDN…

Intended purpose

To puncture the interatrial septum during a transseptal catherisation procedure to gain left heart access.

Functional description

The BRK Transseptal Needle consists of a luminal stainless steel needle and solid stainless stylet. The distal end is curved to facilitate positioning. Within this curved section there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the dilator. The distal tip is beveled to facilitate the puncture process. The proximal end is configured with a pointer flange and is fitted with a 2-way stopcock to provide needle lumen access.

TGA Public Summary