Device Dossier

Ultraverse® 035 PTA Dilatation Catheters - Catheter, angioplasty, balloon dilatation

Device Dossier for Ultraverse® 035 PTA Dilatation Catheters - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class…

Intended purpose

The Ultraverse® 035 PTA Dilatation Catheter is intended to dilate stenoses in the peripheral arteries, to treat obstructive lesions of native or synthetic AV fistulae and/ or re-expand endoluminal stent graft elements in the iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Functional description

A semi-compliant balloon catheter consisting of an over the wire catheter with an angioplasty balloon fixed at the distal tip and compatible with .035" guidewires. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter also includes a radiopaque, atraumatic tip. GeoAlign™ Marker Bands are designed to be used as a location reference tool. Proximally the catheter includes a female luer lock hub with guidewire and inflation lumens.

TGA Public Summary