Device Dossier
SwiftNINJA Steerable Coronary Microcatheter - Intravascular microflow catheter
Device Dossier for SwiftNINJA Steerable Coronary Microcatheter - Intravascular microflow catheter (Intravascular microflow catheter, Class III, sponsor…
- GMDN category: Intravascular microflow catheter
Intended purpose
The micro catheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub selective region has been accessed, the micro catheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The micro catheter should not be used in the cerebral vessels.
Functional description
The SwiftNINJA is a microcatheter with a steerable/articulating distal tip, which is achieved via a steering dial at the proximal handle which allows the operator to manipulate the tip up to 180 degrees in opposing directions. The steering dial and steerable tip are connected via two operating wires on the walls of the catheter shaft with a connection point on the distal catheter. The tip direction can be locked with the steering dial lock maintaining the intended direction.