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The FlexSeal® Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices, and to minimize blood loss associated with such insertions.

The FlexSeal Introducer set contains the following disposable components: One sterile introducer sheath with an active spring loaded hemostatic valve ● One sterile radiopaque dilator The FlexSeal Introducer set consists of an introducer sheath with hydrophilic coating and a dilator. The device size is 21Fr with a 56 cm shaft. An active hemostatic valve is integrated into the sheath. A Ring Lock at the proximal end of the device assists with the control of the hemostatic valve.

This document is a 510(k) Premarket Notification for a medical device called the FlexSeal™ Introducer Sheath with Hydrophilic Coating. It seeks to demonstrate substantial equivalence to a predicate device and does not involve AI or software performance. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from this document.

The document primarily focuses on demonstrating that the new device, a line extension, has similar technological characteristics and performance to its previously cleared predicate device, the FlexSeal Introducer Sheath with Hydrophilic Coating (K161659). The performance data presented are for physical and biocompatibility tests of the device itself, not for an algorithm's performance.

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