SafeSept Transseptal Guidewire? - Transseptal needle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
19-07-2021

可用日期:

Life Systems Medical Pty Ltd

类:

Class III

厂商:

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

治疗领域:

47248 - Transseptal needle

疗效迹象:

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.

授权状态:

A

授权日期:

2021-05-27

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