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The MIVI Mi-Axus™ Guide Catheter is indicated for use in facilitating the insection and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

The MIVI Mi-Axus 8F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary, or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. Additionally, the distal segment of the PEBAX shaft of the 8F device is impregnated with Barium Sulfate (BaS04) for increased radiopacity. A luer hub on the proximal end allows attachments for flushing, insertion of catheters, and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MIVI Mi-Axus Guide Catheter has a straight distal tip and is available in lengths of 80 or 90 cm and an 8F diameter.

The provided text describes a 510(k) summary for the MIVI Mi-Axus™ Guide Catheter. It does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML medical device. Instead, it details the functional, biocompatibility, and sterilization testing performed for a guide catheter.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence for a medical device (a guide catheter) based on its physical properties, materials, intended use, and comparison to predicate devices, rather than on the performance metrics of an AI/ML algorithm.

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