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The angioscopic valvulotome kit is intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass.

The angioscopic valvulotome kit, intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass, consists of commercially available components cleared under previous and/or separate 510k premarket notifications: the GORE EZE-Sit Valvulotome, an angioscope, and an irrigation system. All kit components will be used within their labeled and FDA-cleared indications; the only difference is that GORE will write a single Instructions for Use document to facilitate surgical use.

This document is a premarket notification summary for a medical device (K964061) and does not contain information about acceptance criteria or a study proving the device meets those criteria. The submission focuses on device description, predicate devices, intended use, and technological characteristics to establish substantial equivalence with existing devices, rather than presenting new performance study data.

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