Device Dossier

Atlas - Catheter, angioplasty, balloon dilatation

Device Dossier for Atlas - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III, sponsor Bard). ARTG record,…

Intended purpose

Intended for use in Percutaneous Transluminal Angioplasty of the iliac arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Functional description

It is a Percutaneous Transluminal Angioplasty catheter with a coaxial shaft and a balloon available in various sizes. The balloon is an underlying PET balloon with layers of UHMW Polyethylene strands, bonded with a Pebax outer layer. Packaged with every catheter is a profile reducing sheath that is positioned over the balloon for protection before use.

TGA Public Summary