Are Flexicath products considered safety devices?
A. The current version of the product uses an unprotected needle (similar to the standard TFX introducers), which are not considered safety devices. Flexicath is currently at work on integrating a safety needle into the introducer. It should be available for sale in Q4 2008. The needle-safe aspect of Flexicath products are also intrinsically related to their use. They are designed to replace multistick procedures, so using Flexicath systems during procedures that require a number of standard cannulas (where each cannula requires a new needle) will require only one needle. At a later stage, the standard needle will be replaced with a safety needle.
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