SafeSept Transseptal Guidewire? - Transseptal needle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

Download 공공 평가 보고서 (PAR)
19-07-2021

제공처:

Life Systems Medical Pty Ltd

수업:

Class III

Manufactured by:

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

치료 영역:

47248 - Transseptal needle

치료 징후:

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.

승인 상태:

A

승인 날짜:

2021-05-27

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