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Indications for Use: The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectorny of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System is provided sterile for single-use.

The provided text is related to a 510(k) submission for a medical device called the "SilverHawk™ Peripheral Plaque Excision System." It describes the classification, predicate device, and confirms its substantial equivalence for marketing. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a summary of the 510(k) notification and the FDA's clearance letter, which focuses on regulatory aspects such as substantial equivalence to a predicate device and adherence to general controls. It does not detail the technical studies, performance metrics, or clinical trial data that would typically be included in a full submission to demonstrate safety and efficacy.

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