Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)

The Splashwire Hydrophilic Guide Wire is a sterile, single-use medical device consisting of a nitinol core wire with a polyurethane jacket containing tungsten for radiopacity, coated with a hydrophilic surface. It is intended for use in the peripheral vascular system to facilitate placement of catheters and other devices during diagnostic and interventional procedures, but not for coronary angioplasty or neurovasculature applications.

The subject device shares the same fundamental construction as the predicate (nitinol core, tapered distal section, tungsten-loaded polyurethane jacket, hydrophilic coating, multiple-loop flush dispenser with J-straightener) but incorporates two new line extensions: J-Tip variants with a 1.5 mm J-shaped distal tip, and Long Taper variants with extended core wire taper length for enhanced flexibility.

Testing was based on FDA Guidance documents for Coronary, Peripheral, and Neurovascular Guidewires Performance Tests (October 2019), Intravascular Catheters with Lubricious Coatings (October 2019), Sterility submissions (January 2016), and ISO 10993-1:2018 and ISO 10993-18:2020 for biological evaluation and chemical characterization.

The subject device uses identical core technology and manufacturing principles to the predicate device with the same indications for use. The two new variants (J-Tip and Long Taper) represent minor design modifications—adding a J-shaped distal tip geometry and extending the taper length—that do not change the fundamental operating principles or intended peripheral vascular application. Comprehensive bench testing (dimensional, mechanical, coating, compatibility, and simulated use) demonstrated all performance parameters were comparable to the predicate and met predetermined acceptance criteria, establishing that the design modifications do not introduce new failure modes or safety concerns.