SafeSept Transseptal Guidewire? - Transseptal needle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Life Systems Medical Pty Ltd

Class:

Class III

Manufactured by:

Pressure Products Medical Device Manufacturing LLC 1 School Street, Morton, Pennsylvania, 19070 United States Of America

Therapeutic area:

47248 - Transseptal needle

Therapeutic indications:

The SafeSept Transseptal Guidewire? is a nitinol guidewire designed to cross the interatrial septum when supported by a transeptal introducer and be atraumatic when advanced unsupported into the left atrium. A radiopaque coil is positioned on the distal end of the device to provide fluoroscopic localization during the procedure. White printed markers are positioned on the proximal end of the device to provide approximate Transseptal Guidewire tip location relative to the needle tip. The SafeSept Transseptal Guidewire? is used in conjunction with a transseptal needle to create the primary puncture in the interatrial septum and to guide the needle, dilator, and introducer through the septum from the right side of the heart to the left side.

Authorization status:

A

Authorization date:

2021-05-27