Device Dossier

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

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

Intended purpose

The Sapphire NC ULTRA is intended for balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia.

Functional description

The balloon material is made of a minimally compliant material, Ø1.75mm to 4.0mm balloons have a rated burst pressure of 20 atmospheres and Ø4.5mm to 5.0mm balloons have a rated burst pressure of 18 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube.

TGA Public Summary