Device Dossier

VersaCross Transseptal Sheath - Catheter, intravascular, guiding

Device Dossier for VersaCross Transseptal Sheath - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Boston…

Intended purpose

The VersaCross Transseptal Sheath kit is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.

Functional description

Following vascular access using an access needle, the guidewire is introduced and advanced to the required depth. With the guidewire in place, the access needle is withdrawn. The dilator/sheath assembly is threaded over the guidewire using a slight twisting motion into the required location under fluoroscopic guidance. The sheath side port is used for the injection of fluids or to aspirate blood during the procedure or during removal of the transseptal device or dilator.

TGA Public Summary