Access25™ Delivery Microcatheter

The Access25 Delivery Microcatheter is a single-lumen medical device designed to help physicians access distal blood vessels when used with a guide catheter and micro guidewire. It is indicated to deliver diagnostic agents (such as contrast media) and therapeutic devices (such as occlusion coils) to peripheral and neuro vasculature.

The Access25 has identical inner diameter (0.025 in.), proximal outer diameter (0.040 in.), and distal outer diameter (0.037 in.) to the predicate Lantern device. Both use the same medical-grade plastics and metals with hydrophilic proprietary coating. The main difference is available lengths: Access25 offers 150, 160, and 170 cm versus Lantern's 80–160 cm range. Both are single-use, disposable devices sterilized with ethylene oxide.

ISO 10555-1 (catheter mechanical testing), ISO 10993 series (biocompatibility per parts 4, 5, 10, 11, 23), ISO 11135-1 (ethylene oxide sterilization), USP <151> (pyrogen testing), ANSI/AAMI ST72 (LAL testing), and IEC standards for sterilization validation.

The Access25 is substantially equivalent because it has identical intended use, operating principle, design concept, and fundamental technology as the predicate Lantern device. Both are single-lumen delivery microcatheters with the same core dimensions, materials, coating, accessories, and sterilization method. Bench testing (tensile strength, burst pressure, kink resistance, friction, and particulate generation) demonstrates comparable or meeting performance to acceptance criteria. Comprehensive biocompatibility testing shows the device is non-cytotoxic, non-sensitizing, non-hemolytic, and non-thrombogenic. The difference in available lengths and shorter shelf-life (12 vs. 36 months) does not alter the fundamental equivalence in safety and effectiveness.