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The SilverHawk™-R Peripheral Plaque Excision System for Surgical Use is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal vasculature.

The SilverHawk-R Peripheral Plaque Excision System for Surgical Use consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk-R Peripheral Catheter and SilverHawk Cutter Driver.

The SilverHawk-R Peripheral Plaque Excision System for Surgical Use is provided sterile for single-use. The catheter is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 108, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

This device is an atherectomy system. The provided text is a 510(k) summary for the SilverHawk-R Peripheral Plaque Excision System. It establishes substantial equivalence to a predicate device but does not contain information on acceptance criteria or a study proving that the device meets specific performance criteria.

Therefore, I cannot provide the requested information from the given text. The 510(k) summary focuses on demonstrating equivalence to a previously cleared device based on material, design, indications for use, safety, and efficacy, rather than detailing specific performance targets and studies to meet them for this particular submission.

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