Device Dossier

Mozec™ Rx PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Mozec™ Rx PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

Mozec™ Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Mozec™ Rx PTCA Balloon Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

Functional description

Consists of balloon near distal tip with single/double radiopaque marker bands to represent approximate balloon working length at nominal pressure. Two coaxial lumens permit movement of guidewire & balloon inflation. Two markers on proximal shaft approximately indicate exit of balloon catheter tip from guiding catheter. Proximal portion of shaft has PTFE coating & distal portion has hydrophilic coating to optimize proximal pushability with smooth transition to distal shaft trackability.

TGA Public Summary