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TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel excluding use in coronary arteries and in the neurovasculature.

TFX Medical will supply a standard range of guidewires as sterile, packed finished products, and will also supply in bulk to other manufacturer to their specific size requirements (for example: for inclusion in a kit).

The kev features of the TFX Medical Guidewire are:

• O Core Wire
• O Ribbon Wire (where fitted)
• O Spring Wire
• O Welds
• Coating (p.t.f.e. coating or uncoated stainless steel)
• Tips (available straight and "J" forms, one or two tips)

Guidewires will be manufactured of grade 302/304 stainless steel and be available:

• . with and without a ribbon wire
• ♥ in fixed and moveable core designs
• . uncoated and p.t.f.e. coated
• with straight and "J" formed end(s)
• with and without a length marking

I am sorry, but the provided text does not contain the detailed information required to fulfill your request. The document is a 510(k) summary for a medical guidewire and mentions "Test data in the premarket notification demonstrates TFX Medical Guidewires meeting the requirements of the appropriate parts of British Standard BS 7174: 1990: Part 4." However, it does not provide the specific acceptance criteria, reported device performance in a table, details about the study (sample size, data provenance, ground truth, experts, adjudication, MRMC, or standalone performance), or information about the training set.

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