InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

About This 510(k) Submission

K251385 is an FDA 510(k) clearance for the InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S), 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 January 21, 2026, 261 days after receiving the submission on May 5, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.