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Nautiflux is recommended for use in angiographic and coronarographic procedures to inject contrast media and to allow the physician to monitor the blood pressure.

Nautiflux is a universal and compact automatic set consisting of an injection handle and a fluid delivery system for use in angiographic and coronarographic procedures.

The provided text describes the 510(k) summary for the Nautiflux device. However, it explicitly states "Summary of Clinical Tests (Not Applicable)" and does not include any information about detailed performance testing with acceptance criteria, sample sizes, or specific performance metrics.

Therefore, I cannot provide the requested information from the given text. The document indicates that the device's substantial equivalence was based on non-clinical performance testing and equivalence in indications for use, design, material, and function to previously cleared devices, rather than a clinical study with detailed acceptance criteria and reported performance.

Based on the provided text, the answer is that the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets them.

The sections that would typically contain this information (like performance data, clinical trial results, or detailed non-clinical testing outcomes with pass/fail criteria) are either explicitly stated as "Not Applicable" for clinical tests or are summarized with a general statement that "Performance testing was presented" without specifying the criteria or results.

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