Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter

The Excelsior XT-27 Microcatheter is a sterile, single-lumen catheter with a 0.027-inch inner diameter designed to assist in delivering embolization particles, diagnostic agents (contrast media), and interventional devices (stents) into the neurovasculature. It features a hydrophilic coating, radiopaque tip marker, and is available in straight or pre-shaped configurations with two distal shaft lengths (6 cm standard or 18 cm flex model).

The subject device is identical to the predicate in materials (PTFE, Pebax, stainless steel, nylon, Santoprene), dimensions (2.9F proximal OD, 2.7F distal OD, 0.027-inch ID), coating type (hydrophilic polymer), tip marker (platinum-iridium alloy), effective lengths (135 or 150 cm), and sterilization method (EtO gas). The only change is the revised labeling to recommend compatibility with guide catheters having a minimum inner diameter of 0.046 inches (1.17 mm) instead of prior guidance.

EN ISO 14971 (risk management for medical devices) was applied to the risk assessment. The submission does not cite specific consensus standards like ASTM or IEC for performance testing.

Substantial equivalence is established because the subject device maintains the same intended use, materials, fundamental design, and operating principles as the predicate (K113778). The modification is limited to labeling guidance on guide catheter compatibility (0.046-inch minimum ID). Bench testing confirmed the microcatheter performs safely and effectively within the smaller guide catheter, with passing results for compatibility forces, tensile strength, and coating integrity. Since only the labeling changed and performance was validated, no new safety or effectiveness questions arise.