Central venous catheter electrocardiographic navigation system

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Florey Medical Pty Ltd

classe:

Class IIa

Fabriqué par:

SC Romedex International SRL etaj4 74 Fundeni Street Sector 2, Bucharest, 022325 Romania

Domaine thérapeutique:

61564 - Central venous catheter electrocardiographic navigation system

indications thérapeutiques:

An assembly of noninvasive devices intended to use electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC), central venous catheter (CVC), haemodialysis catheter]. It includes a portable battery-powered control unit, ECG cable(s), and ECG leads(s). The catheter (not included) is used as an intravascular electrode, with the guidewire or intraluminal saline used as a conductor. The control unit processes ECG signals and sends them to a separate off-the-shelf device (e.g., smartphone), whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data.

Statut de autorisation:

A

Date de l'autorisation:

2015-05-14