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FDA 510(k)

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)

K-Number: K251181 · 2025-08-29

ApplicantMerit Medical Ireland, Ltd.
Decision Date2025-08-29
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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) is a medical device manufactured by Merit Medical Ireland, Ltd.. It received FDA 510(k) clearance on 2025-08-29 under approval number K251181. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is 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)?

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) is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by Merit Medical Ireland, Ltd.. The 510(k) number is K251181.

When was 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) approved by the FDA?

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) received FDA 510(k) clearance on 2025-08-29, under approval number K251181.

What company makes 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)?

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) is manufactured by Merit Medical Ireland, Ltd..

What is the FDA product code for 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 FDA product code for 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) is DQX.

Other Devices by Merit Medical Ireland, Ltd.

K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) K251385InQwire 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)

Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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