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Indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:

• Lack of usable peripheral IV sites .
• Central venous pressure monitoring .
• Total parenteral nutrition (TPN) .
• . Multiple infusions of fluids, medications, or chemotherapy
• Frequent blood sampling or receiving blood transfusions/blood products .
• . Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
• Injection of contrast media in pressure CVC only .

When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 300psi.

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The provided text is a 510(k) premarket notification letter from the FDA to Ameco Medical Industries for their "Amecath CVC" and "Amecath Pressure CVC" short-term single and multi-lumen catheterization kits.

This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria for a device's performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval, classification, and general responsibilities under the Federal Food, Drug, and Cosmetic Act.

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