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The Floppy and Intermediate guide wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are a 0.014 inch size and designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.

The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch. The guide wires are 175 cm long (nominal) and have a 30 cm radiopaque spring coil joined distally to a central stainless steel core wire. The core wire and spring coils are coated with a hydrophilic phosphorvicholine polymer.

This document is a 510(k) summary for a medical device (guide wires), not a study report. Therefore, it does not contain the information requested about acceptance criteria, study design, or performance metrics typically found in clinical studies or validation reports.

Specifically, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, and training set details) is absent from this 510(k) summary.

This document describes the device, its intended use, and identifies a predicate device for substantial equivalence, which is a regulatory filing requirement, not a detailed performance study.

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