Armada 35 PTA Catheter - Catheter, angioplasty, balloon dilatation

Intended purpose

The device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Functional description

The Armada 35/Armada 35 LL Percutaneous Transluminal Angioplasty (PTA) Catheter is a standard over-the wire (OTW) balloon catheter to be used for PTA.The balloon is inflated using the side leg port of the Y-arm luer and expands to a known diameter at specific pressure.All balloons distend to sizes above the nominal diameter at pressures greater than the nominal pressure.