Retrograde Cardioplegia Catheter - Cannula, coronary sinus

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
20-07-2021

MAH:

Edwards Lifesciences Pty Ltd

class:

Class III

manufactured_by:

Edwards Lifesciences LLC One Edwards Way, Irvine, California, 92614 United States Of America

therapeutic_area:

36109 - Cannula, coronary sinus

therapeutic_indication:

Designed to deliver cardioplegia solution and to provide occlusion or venting to the coronary sinus during cardiothoracic procedures while the patient is managed using cardiopulmonary bypass. The catheter has 2 or 3 lumens to deliver solution, monitor pressure within the coronary sinus, and if a third lumen is present, it either facilitates the manually inflated balloon, or the stiffening wire. It includes a manually inflating or self-inflating smooth or textured occlusion balloon. Intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection.

authorization_status:

A

authorization_date:

2021-03-02