Search Results

The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

The provided text is a 510(k) summary for the AngioSculpt PTA Scoring Balloon Catheter, which is a medical device. This document describes the device, its intended use, and the testing performed to demonstrate its safety and effectiveness for substantial equivalence to predicate devices. It does not provide information relevant to the acceptance criteria and study design for a software algorithm/AI device. Therefore, I cannot extract the requested information.

Ask a specific question about this device