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Term Corporation SPECIAL 510(K) TERM Surshielde Safety I.V. Catheter (51 mm catheter length) Section II. 5 10(k) Summary!vIAy1 2009Section II. 510(k) SUMMARY A. Device Name Proprietary Name TERM Shield

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What is special 510k - terumo?

Special 510(k) - Terumo is a type of premarket submission made to the FDA to demonstrate that a proposed change to a device already on the market complies with regulations and does not introduce new risks.

Who is required to file special 510k - terumo?

Medical device manufacturers who intend to make modifications to their existing devices that could affect safety or effectiveness are required to file a special 510(k) submission.

How to fill out special 510k - terumo?

To fill out a special 510(k) submission for Terumo, manufacturers need to provide detailed information about the proposed device modification, data supporting the change's safety and effectiveness, and any other relevant documentation requested by the FDA.

What is the purpose of special 510k - terumo?

The purpose of a special 510(k) submission for Terumo is to demonstrate that a proposed device modification meets FDA regulations and does not pose new risks to patients or users.

What information must be reported on special 510k - terumo?

Information that must be reported on a special 510(k) submission for Terumo includes details about the proposed device modification, data supporting the change's safety and effectiveness, and any other relevant documentation requested by the FDA.

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