Device Dossier

Dorado PTA Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for Dorado PTA Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class…

Intended purpose

Recommended for use in Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. 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

Balloon catheter consisting of an OTW catheter with balloon fixed at distal tip. Two radiopaque markers delineate the working length of balloon & aid in balloon placement. Cather consists of a distal triple & a proximal coaxial lumen. Compatible with a 0.035" g/wire. The proximal portion of the catheter includes a female luer lock hub connected to inflation lumen, & a female luer lock hub connected to g/wire lumen.

TGA Public Summary