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The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.

The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The NEEDLE'S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects.

The devices consist of sheaths and snares intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, and foreign objects and/or in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.

This 510(k) Premarket Notification for COOK Vascular™ Intravascular Retrieval Devices does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it is a submission notifying the FDA of revisions made to previously cleared devices. The document claims "No changes have been made to the devices; they are substantially equivalent to the predicate devices, having the same intended use and technological characteristics." Therefore, the submission relies on the prior clearance of the predicate devices for its regulatory approval.

Specifically, the document states:

• "The 510(k) submission serves to notify FDA of labeling revisions made to previously cleared devices. No changes have been made to the devices; they are substantially equivalent to the predicate devices, having the same intended use and technological characteristics."

Given this, I cannot provide the requested information about acceptance criteria or a study that proves the device meets them because such information is not present in the provided text. The submission is a claim of substantial equivalence based on no changes to the device itself.

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