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Special 510(k) Notification Infuser SV and LV Elastomeric Infusion Devices Section 5, 510(k) Summary 5.510(K) SUMMARY DATE PREPARED: April 10, 2007, MAY A6 2007 OWNER: Baxter Healthcare Corporation

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What is special 510k notification?

Special 510k notification is a premarket submission made to the FDA to demonstrate that a modification to a device subject to a 510k clearance is as safe and effective as the original device.

Who is required to file special 510k notification?

Manufacturers are required to file a special 510k notification if they make a modification to a device that has already received 510k clearance.

How to fill out special 510k notification?

Special 510k notifications must be completed and submitted electronically through the FDA's eSubmitter program.

What is the purpose of special 510k notification?

The purpose of special 510k notification is to demonstrate that a modified device remains safe and effective without the need for new clinical data.

What information must be reported on special 510k notification?

Special 510k notifications must include detailed information on the modifications made to the device, as well as any potential impacts on safety and effectiveness.

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