(86 days)
Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
The Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy consists of a clear PVC, implant tested, PVC tracheal tube with radiopaque (BaSO4) stripe. The radiopaque stripe runs the entire length of the Tracheal Tube. The cuff is inflated via a valved pilot balloon using lock-The main tube is graduated tip or luer taper syringe. multiple centimeter markings to allow easv with determination of intubation length. A black positioning ring is present on the tube to aid in visualization of An optional Murphy eye provides an alternative the tube. opening. The device is for nasal and oral use.
This 510(k) submission, K993786, for the Rüsch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy, does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or performance data in the format requested.
The document is a traditional 510(k) summary, which focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting detailed performance validation studies with specific acceptance criteria and statistical analysis.
Therefore, I cannot provide the requested information. The document primarily identifies the device, its intended use, and its substantial equivalence to previously marketed devices.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).