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The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 4.0 mm balloon diameters are also indicated for postdilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.

The Armada 14 PTA Catheter is a standard over-the-wire (OTW) balloon catheter to be used for percutaneous transluminal angioplasty (PTA). It is available in balloon lengths of 20 mm to 200 mm, with nominal diameters of 1.5 mm to 4.0 mm. The balloon has a nominal diameter inflation pressure of 8 atm and a rated burst pressure of 14 atm. Two polymer marker bands mark the working length of the balloons. The catheter shaft has working lengths of 90 and 150 cm. The inner lumen will accept a 0.014" guide wire. The outer shaft has a polycarbonate y-arm fuer adhesively bonded to the proximal end to allow for entry to the guide wire lumen and to allow for connection of the inflation device to the inflation/deflation lumen.

This is a medical device, not an AI/ML device. The provided text is a 510(k) summary for the Armada 14 PTA Catheter, outlining its design, intended use, and performance testing for regulatory clearance. It does not involve AI or machine learning algorithms, and therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable.

The performance data section describes standard tests for a medical catheter (e.g., Simulated Use, Balloon Compliance, Biocompatibility), which are engineering and biological validations, not related to AI/ML model performance.

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