Device Dossier

Sapphire II NC Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Sapphire II NC Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

Sapphire II NC 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 NC Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Ø1.75 mm to 4.0 mm balloons have a rated burst pressure of 20 atmospheres and Ø4.5 mm to 5.0 mm balloons have a rated burst pressure of 18 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.

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