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The ULTRASKIN™ Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure.

The ULTRASKIN™ Hydrophilic Guide Wire consists of a Nitinol core wire, a plastic jacket with hydrophilic coating. The wire distal curve comes in different shapes such as straight, J angled and angled. The guide wire is radiopactitive under fluoroscopy.

The provided text describes the ULTRASKIN™ Hydrophilic Guide Wire, a medical device, and its supporting data for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from international standards and internal performance testing, demonstrating safety and effectiveness compared to a predicate device.

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