Search Results

The 87 NeuGlide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Piraeus Medical 87 NeuGlide Catheter is a single lumen guide catheter that provide access to peripheral, coronary and neuro vasculature. The catheter is comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The catheter features a hydrophilic coating to enhance tracking through tortuous vasculature and facilitate the introduction of interventional devices to the peripheral, coronary and neurovasculature. The 87 NeuGlide guide catheter is compatible with 0.035" or smaller guidewires. The distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The 87 NeuGlide Catheter has an inner diameter of 0.087″ (6F compatible), and a maximum outer diameter of 0.100″. The catheter is offered in working lengths of 110 and 100 cm. The 87 NeuGlide guide catheter is packaged with a loading tool to aid in insertion of the catheter into a short sheath.

The provided text describes the 510(k) summary for the "87 NeuGlide Catheter" and details of the performance data supporting its substantial equivalence to a predicate device. However, this document does not contain information about an AI/algorithm-based device.

Therefore, I cannot provide a description of acceptance criteria and the study that proves an AI device meets those criteria based on the provided text. The document refers to a physical medical device (a catheter) and discusses its mechanical, biocompatibility, and sterilization properties, not an AI or software component for image analysis or diagnosis.

If you have a document related to an AI/algorithm medical device, I would be happy to analyze that.

Ask a specific question about this device