Device Dossier
Sapphire II Pro Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic
Device Dossier for Sapphire II Pro Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter,…
- GMDN category: Angioplasty catheter, balloon dilatation, coronary, basic
Intended purpose
Sapphire II Pro is indicated for balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
Functional description
Sapphire II Pro Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. 1.0mm to 1.5mm balloons have a rated burst pressure of 16 atmospheres and 1.75mm to 4.0mm balloons have a rated burst pressure of 14 atmospheres. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire.