APRO 70 Swift Catheter

The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter designed to facilitate insertion and guidance of interventional devices into peripheral and neurovascular blood vessels. It features a hydrophilic coating on the distal segment, a radiopaque marker at the tip for fluoroscopic visualization, and is provided with an introducer sheath for sterile, single-use disposable application.

The subject device is larger than the predicate (0.083 inch outer diameter vs. 0.066 inch) with a 0.070 inch inner diameter versus 0.055 inch. Both use identical materials: 304V stainless steel braid and coil, thermoplastic polyurethanes, PTFE/Tecoflex liners, platinum/iridium markers, and hydrophilic coatings. The subject device offers different effective lengths (125, 132, 135 cm vs. 125, 137 cm) and coated lengths (90, 97, 100 cm vs. 90, 102 cm), and has a 1-year shelf life versus 6 months for the predicate.

ISO 10555-1 (catheter hub air leakage and liquid leakage), ISO 80369-7 (hub compatibility), ISO 11135 (ethylene oxide sterilization), ISO 10993-1 (biocompatibility evaluation), and FDA guidance on biological evaluation of medical devices.

Substantial equivalence is supported by identical materials, design concept, and fundamental operating principles between subject and predicate devices. Non-clinical bench testing demonstrates the subject device meets or exceeds all performance specifications including kink resistance, torque strength, burst pressure, tensile strength, and simulated use with stent retrievers. Biocompatibility testing confirms non-sensitizing, non-irritant, and non-cytotoxic properties. The size increase and longer shelf life represent improvements that do not raise new safety or effectiveness concerns, as all mechanical performance and biocompatibility metrics are equivalent or superior to the predicate.