Socrates 38 Catheter

The Socrates™ 38 Catheter is a single-lumen, variable stiffness catheter designed to facilitate insertion and guidance of microcatheters or diagnostic agents into peripheral and neurovasculature. It features a nitinol and polymer shaft with hydrophilic coating, radiopaque tip marker, and is supplied sterile for single use.

Compared to the predicate Modified HD Guide Catheter, the Socrates™ 38 has slightly larger outer diameter (0.053" vs 0.051"), uses different hub material (polycarbonate vs PEBAX), different strain relief (stainless steel vs polyolefin), different radiopaque marker (tantalum vs platinum/iridium), and offers three effective lengths (115, 127, 156 cm vs 105-136 cm range). The hydrophilic coating length is specified at 90 cm versus unknown for the predicate.

ISO-10555-1:2014 (catheter testing), ISO-10993-1:2018 (biocompatibility), ISO-80369-7 (luer design verification). Tests include tensile/elongation, tip stiffness, kink radius, liquid leak, burst pressure, dynamic flow, torque, flexural fatigue, and corrosion resistance.

The device has the same intended use (vascular access) and nearly identical indications as the predicate, differing only in exclusion of coronary use. Minor dimensional and material differences do not raise new safety or effectiveness questions because both devices function identically as guide catheters in neurovasculature. Comprehensive non-clinical performance testing—including functional, biocompatibility, and sterilization studies—all passed acceptance criteria and demonstrated performance comparable to the predicate, supporting substantial equivalence without clinical data.