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…
- GMDN category: Angioplasty catheter, balloon dilatation, coronary, basic
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.