Teleport Glide Microcatheter

The Teleport Glide Microcatheter is a single-lumen catheter designed for use in peripheral blood vessels. It guides and supports a guidewire, allows for guidewire exchange, and delivers contrast media into peripheral vasculature. The device is available in three sizes with working lengths ranging from 65cm to 200cm and is compatible with standard 0.018-inch or 0.035-inch guidewires.

The device has the same indications for use, similar catheter design, similar materials of construction, and same sterilization method as predicate devices. Technological differences include specific materials selected and exact dimensions of components. The catheter has a hydrophilic polymer coating on the outer surface for lubricity and a fluoropolymer-lined lumen to facilitate guidewire movement.

Not stated in this summary. The document references ISO 13485 clauses for design controls, nonconforming product, corrective action, and preventative action, but does not cite specific consensus standards for device testing.

The Teleport Glide Microcatheter is substantially equivalent to three predicate devices (Navicross 0.018", Terumo Support Catheter, and R2P Navicross) because it shares the same indications for use, similar design and materials, and equivalent sterilization methods. Comprehensive performance testing including sterilization, shelf-life, mechanical properties, biocompatibility, and hemocompatibility all met acceptance criteria, demonstrating that the design and construction are suitable for the intended use.