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)

About This 510(k) Submission

K251181 is an FDA 510(k) clearance for the 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), a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Merit Medical Ireland, Ltd. (Galway H91 Vy19, IE). The FDA issued a Cleared decision on August 29, 2025, 135 days after receiving the submission on April 16, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.