(28 days)
The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.
The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon material expands to a known diameter at specific pressure.
This document is a 510(k) summary for a medical device called the Fox Plus PTA Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or any comparative effectiveness studies as requested in the prompt.
Therefore, I cannot provide the requested table and information based on the provided text. The submission focuses on demonstrating substantial equivalence through non-clinical testing, but the details of those tests and their outcomes are not included here.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).