Amethyst HP PTA OTW 0.035 Catheter

The Amethyst HP PTA OTW 0.035" Catheter is a balloon angioplasty catheter used to open narrowed peripheral blood vessels (in arteries like the iliac, femoral, and tibial) and to dilate stents in peripheral circulation. It is an over-the-wire device with a non-compliant balloon at the distal tip, radiopaque markers for positioning, and a Luer lock hub for inflation and guidewire access.

The device design, materials, and manufacturing are the same or similar to the predicate Conquest™ 40 PTA Dilatation Catheter. It features a co-axial dual-lumen design with balloon inflation via lateral port and guidewire passage via the central lumen, sized in balloon diameters from 7–10 mm and lengths from 20–100 mm, supplied sterile for single use.

ISO 10993 Biological Evaluation of Medical Devices Part-1, 21 CFR 58 (GLP regulations), and applicable design verification/validation testing including balloon fatigue, burst pressure, compliance, torque strength, flexibility, kink resistance, and package integrity testing.

The device is substantially equivalent because it shares the same indications for use (peripheral PTA and stent post-dilatation), employs identical or similar design principles and materials as the predicate, and demonstrates equivalent performance through non-clinical testing covering dimensional, mechanical, and biocompatibility parameters with no new safety or effectiveness concerns identified.