COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)

The COREPASS Modular Microcatheter (FLEX and CONTROL variants) is a single-lumen catheter designed for use in coronary, peripheral, and abdominal vasculature. It is indicated for supporting and facilitating guidewire placement, exchanging guidewires, and delivering contrast media. The device is offered in two shaft sizes (2.2F and 2.5F) with working lengths of 135 cm or 150 cm.

The device shares the same indications, similar catheter design, similar materials of construction, same hydrophilic coating, and same sterilization method as the predicate. Differences include specific materials selected and exact dimensions of components. The catheter is compatible with 0.014-inch guidewires and has a hydrophilic polymer coating on the distal 60 cm.

Not stated in this summary.

The COREPASS device demonstrates substantial equivalence through identical indications for use, similar design architecture, and comparable materials and coating technology as the Teleport XT predicate. Comprehensive performance testing—including sterilization, burst pressure, guidewire compatibility, and biocompatibility assays (cytotoxicity, hemocompatibility, thrombogenicity)—met the same acceptance criteria as the predicate and reference devices, confirming that the minor differences in specific materials and component dimensions do not affect safety or effectiveness for the intended clinical applications.