Device Dossier
Central venous catheter electrocardiographic navigation system
Device Dossier for Central venous catheter electrocardiographic navigation system (Central venous catheter electrocardiographic navigation system, Class…
Intended purpose
This is a non-sterile, reusable component (single product only) of a catheter navigation system which, when used with dedicated accessories [supplied separately], is intended to provide real time tip location information of a CVAD [central venous catheter] by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the superior vena cava.