Echo Large Bore Introducer Sheath

The Echo Large Bore Introducer Sheath is a single-use vascular access device consisting of a hydrophilic, coil-reinforced catheter with an attached hemostatic valve and twist-locking dilator. It is inserted into the vasculature to provide a conduit for endovascular device insertion while minimizing blood loss. The device is available in sizes from 10-26 French with lengths from 33-65 cm.

Key differences from the predicate (Gore DrySeal Flex) include: omission of a provided syringe (requires standard off-the-shelf 10mL syringe instead); addition of barium sulfate to the dilator for enhanced radiopacity; a shallow groove in the dilator that mates with the sheath tip for smooth transition, secured by a proximal locking lever; and a visual indicator reflecting valve seal inflation pressure. Indications for use, sheath sizes, sterilization method, and principles of operation remain identical to the predicate.

ISO 13485 (Quality Management System), ISO 10993-1 (Biocompatibility evaluation), ISO 11135 (Ethylene oxide sterilization validation). Biocompatibility testing included cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, and hemocompatibility (hemolysis, complement activation, platelet/leukocyte, partial thromboplastin time, thrombogenicity).