Cleared Special

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

K253847 · Merit Medical Ireland, Ltd. · Cardiovascular
Jan 2026
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K253847 is an FDA 510(k) clearance for the Splashwire Hydrophilic Guide Wire (MSWSTD35150J3), a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Merit Medical Ireland, Ltd. (Galway, IE). The FDA issued a Cleared decision on January 31, 2026, 60 days after receiving the submission on December 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K253847 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2025
Decision Date January 31, 2026
Days to Decision 60 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

Similar Devices — DQX Wire, Guide, Catheter

All 760
EmeryGlide? (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
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)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026
Lunderquist Extra Stiff Wire Guide
K251596 · William Cook Europe Aps · Nov 2025
SureAx-Guide?
K250203 · Sureax Medical, LLC · Oct 2025
Amplatzer Guidewire
K250031 · Abbott Medical · Oct 2025

More from Merit Medical Ireland, Ltd.

View all
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)
K251385 · DQX · Jan 2026
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)
K251181 · DQX · Aug 2025
BASIXCONPAK ANALOG INFLATION SYRINGE
K122321 · MAV · Dec 2012