510(k) K253847

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) by Merit Medical Ireland, Ltd. — Product Code DQX

K253847 is an FDA 510(k) premarket notification submitted by Merit Medical Ireland, Ltd. for the device "Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)". The FDA issued a decision of Substantially Equivalent on January 31, 2026. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Merit Medical Ireland, Ltd. has at least 5 other 510(k) clearances on record.