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The 5F Dignity® Midsize CT Titanium Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

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This document is a 510(k) clearance letter from the FDA for the 5F Dignity® Midsize CT Titanium Port. It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the provided text DOES NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• The FDA's decision regarding the 510(k) submission (K130923).
• The device name: 5F Dignity® Midsize CT Titanium Port.
• The device's regulation number, name, and class.
• General controls provisions of the Act that apply to the device.
• Indications for Use for the device.

To answer your request, I would need a different document, likely a section from the 510(k) submission itself (e.g., a "Performance Data" or "Clinical Study" section), which would detail the specific tests conducted, their acceptance criteria, and the results.

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