SafeSept Transseptal Guidewire? - Transseptal needle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Life Systems Medical Pty Ltd

Klasse:

Class III

Fremstillet af:

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

Terapeutisk område:

47248 - Transseptal needle

Terapeutiske indikationer:

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.

Autorisation status:

A

Autorisation dato:

2021-05-27