Device Dossier
Catheter, intravascular, guiding
Device Dossier for Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class IIa, sponsor Diverse Devices). ARTG record, intended…
- GMDN category: Catheter, intravascular, guiding
Intended purpose
Indications for Use The Wingman Crossing Catheters are intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents Device Description The Wingman Crossing Catheters are devices intended to provide additional support to a steerable guidewire(0.014 and 0.035) when accessing discrete regions of the peripheral vasculature The catheter is tracked over a guidewire to the occluded lesion. The guide tip is in the retracted position during tracking over the guidewire. Upon reaching the occlusion, the guide tip is advanced forward, rotated and retracted using the advancer on the handle. The advancement and retraction of the guide tip creates a small channel that then allows the wire to penetrate and cross the lesion. This step can be repeated until the occlusion is crossed. When the guide tip is in the normal mode it is retracted just flush to the catheter. When it is activated it is extended just distal to the tip